Transfemoral Osseointegration in Association With Total Hip Replacement: Observational Cohort Study of Patients With Follow-Up Exceeding 2 Years.

Background: Some amputees with transfemoral osseointegration (TFOI) have ipsilateral hip arthritis which can be addressed with total hip arthroplasty (THA). This study reported the medium-term outcomes of THA in association with TFOI (THA + TFOI). Methods: Retrospective review was performed for eight patients with THA + TFOI performed at least 2 years prior. Primary outcomes include complications prompting surgical intervention. Secondary outcomes include changes in mobility (K-level, 6-minute walk test [6MWT], timed up and go) and patient-reported measures (hip pain, daily prosthesis wear hours, Questionnaire for Persons with a Transfemoral Amputation, and Short Form 36 [SF36]). Results: One patient died after 11 months (cancer); he was included to maximally report complications but excluded from mobility and reported outcomes. Three patients required subsequent surgeries: Two had skin refashioning, and the other underwent hip debridement of the replaced joint with subsequent removal of the TFOI. No perioperative complications, fractures, or arthroplasty explantations occurred. All patients reported complete hip pain relief. Of 6 patients reporting prosthesis wear time, 2 (33%) wore their prosthetic leg at least 4 hours daily before, vs all (100%) who did afterward (P = .061). K-levels improved in all responding patients. All 5 wheelchair-bound patients achieved and maintained ambulation. The Questionnaire for Persons with a Transfemoral Amputation and Short Form 36 did not significantly change. Conclusions: THA + TFOI does not appear to pose an inevitable risk for prosthetic hip infection and may improve mobility and enhance quality of life (QOL) for transfemoral amputees with concurrent arthritic hip pain who are dissatisfied with their outcome following traditional socket prosthesis rehabilitation.

Single-Stage Press-Fit Osseointegration of the Radius and Ulna for Rehabilitation After Trans-Forearm Amputation.

Background: Upper limb (UL) amputation is disabling. ULs are necessary for many domains of life1, and few effective motor and sensory replacements are accessible2. Approximately 41,000 people in the United States have UL amputation proximal to the fingers3, two-thirds of (all) traumatic amputations are UL4, and 80% of UL amputations are performed for trauma-related etiologies5. Socket prosthesis (SP) abandonment remains high because of the lack of sensation, limited prosthesis control, perceived weight, and difficulty comfortably wearing the SP6. Transcutaneous osseointegration7,8 surgically inserts a bone-anchored implant, passed through a transcutaneous portal to attach a terminal device, improving amputee rehabilitation by reducing perceived weight, conferring osseoperception9, and increasing wear time10. Without the socket, all residual skin and musculature remain available for transcutaneous myoelectrodes. The present article describes single-stage radius and ulna press-fit osseointegration (PFOI) after trans-forearm amputation. Description: This technique resembles a lower-extremity PFOI11,12. Importantly, at-risk nerves and vessels are different, and implant impaction must be gentler as a result. The surgery is indicated for patients who are dissatisfied with SP rehabilitation or declining alternative rehabilitative options, and who are motivated and enabled to procure, train with, and utilize a forearm prosthesis. An engaged prosthetist is critical. Surgical steps are exposure, bone-end and canal preparation, first implant insertion (in the operative video shown, in the radius), purse-string muscle closure, confirmation that radius-ulna motion remains, performing the prior steps for the other bone (in the video, the ulna), and closure (including potential nerve reconstruction, soft-tissue contouring, and portal creation). Although the patient in the operative video did not require nerve procedures to address pain or to create targets for transcutaneous myoelectrodes, targeted muscle reinnervation or a regenerative peripheral nerve interface procedure could be performed following exposure. Alternatives: Alternatives include socket modification, bone lengthening and/or soft-tissue contouring13, Krukenberg-type reconstructions14, or accepting the situation. An alternative implant is a screw-type osseointegration implant. Our preference for press-fit implants is based on considerations such as our practice's 12-year history of >1,000 PFOI surgeries; that the screw-type implant requires sufficient cortical thickness for the threads15, which is compromised in some patients; the lower cost per implant; that the procedure is performed in 1 instead of 2 surgical episodes15,16; and the documented suitability of press-fit implants for patients with challenging anatomy or comorbidities17-19. Rationale: PFOI can be provided for amputees having difficulty with socket wear. PFOI usually provides superior prosthesis stability, which can confer better prosthesis control versus nonoperative and other operative options in patients expressing dissatisfaction for reasons such as those mentioned above, or for poor fit, compromised energy transfer, skin pinching, compression, and abrasions. For patients who want myoelectric control of their prosthesis but who are unable because the optimal myoelectric location is obstructed by the socket, osseointegration may provide access for the electrodes by eliminating the socket. Expected Outcomes: Only 3 trans-forearm osseointegration20-22 publications totaling 10 limbs could be identified, limiting the ability to determine generalizable outcomes. Osseointegrated prostheses, being skeletally anchored, feel lighter to patients than SPs, which should confer better outcomes. In 1 patient, multiple implant fractures and infection prompted additional surgeries. Periprosthetic bone fractures and non-infectious loosening have not been documented for UL osseointegration. Important Tips: Osseointegration eliminates the socket, relieving socket-based pain. However, neurogenic pain relief requires specific nerve procedures.Osseointegration provides a prosthesis connection. Nerve- or muscle-based prosthesis control requires separate, potentially integrated planning.Osseointegrated prostheses confer osseoperception (i.e., mechanical force transmission), not "normal" skin-mediated afferent sensation (i.e., light touch, temperature, pain) or native proprioception.Prostheses must be individualized to the patient's elbow flexion and radioulnar rotation. An attentive prosthetist must be ensured preoperatively.Achieving the demonstrated outcomes requires more therapy and retraining than walking with an osseointegrated lower-extremity prosthesis. Patients must expect at least several months of spending multiple hours daily engaging in self-directed rehabilitation.Prosthesis utilization decision aids23 may minimize non-beneficial surgeries. Acronyms and Abbreviations: UL = upper limbSP = socket prosthesisPFOI = press-fit osseointegrationperi-pros fx = periprosthetic fractureMRI = magnetic resonance imagingCT = computed tomography.

Transtibial osseointegration following unilateral traumatic amputation: An observational study of patients with at least two years follow-up.

IMPORTANCE: Most patients use a traditional socket prosthesis (TSP) to ambulate independently following transtibial amputation. However, these patients generally require prosthesis repairs more than twice annually and an entirely new prosthesis every two years. Furthermore, transtibial amputation patients have four times the skin ulceration rate of transfemoral patients, prompting more frequent prosthesis refitting and diminished use. Trans-Tibial osseointegration (TTOI) is a promising technique to address the limitations of TSP, but remains understudied with only four cohorts totaling 41 total procedures reported previously. Continued concerns regarding the risk of infection and questions as to functional capacity postoperatively have slowed adoption of TTOI worldwide. OBJECTIVE: This study reports the changes in mobility, quality of life (QOL), and the safety profile of the largest described cohort of patients with unilateral TTOI following traumatic amputation. DESIGN: Retrospective observational cohort study. The cohort consisted of patients with data outcomes collected before and after osseointegration intervention. SETTING: A large, tertiary referral, major metropolitan center. PARTICIPANTS: Twenty-one skeletally mature adults who had failed socket prosthesis rehabilitation, with at least two years of post-osseointegration follow-up. MAIN OUTCOMES AND MEASURES: Mobility was evaluated by K-level, Timed Up and Go (TUG), and Six Minute Walk Test (6MWT). QOL was assessed by survey: daily prosthesis wear hours, prosthesis problem experience, general contentment with prosthesis, and Short Form 36 (SF36). Adverse events included any relevant unplanned surgery such as for infection, fracture, implant loosening, or implant failure. RESULTS: All patients demonstrated statistically significant improvement post osseointegration surgery with respect to K-level, TUG, 6MWT, prosthesis wear hours, prosthesis problem experience, general prosthesis contentment score, and SF36 Physical Component Score (p < 0.01 for all). Three patients had four unplanned surgeries: two soft tissue refashionings, and one soft tissue debridement followed eventually by implant removal. No deaths, postoperative systemic complications, more proximal amputations, or periprosthetic fractures occurred. CONCLUSIONS AND RELEVANCE: TTOI is likely to confer mobility and QOL improvements to patients dissatisfied with TSP rehabilitation following unilateral traumatic transtibial amputation. Adverse events are relatively infrequent and not further disabling. Judicious use of TTOI seems reasonable for properly selected patients. LEVEL OF EVIDENCE: 2 (Therapeutic investigation, Observational study with dramatic effect).

Techniques to Remove Press-Fit Osseointegration Implants.

Background: Transcutaneous osseointegration for amputees (TOFA) has proven to consistently, significantly improve the quality of life and mobility for the vast majority of amputees, as compared with the use of a socket prosthesis1,2. As with any implant, situations such as infection, aseptic loosening, or implant fracture can occur, which may necessitate hardware removal. Although it may eventually occur, to date no osseointegration implant has ever required removal in the setting of periprosthetic fracture. Since TOFA implants are designed to facilitate robust bone integration, removal can be challenging. Even in cases in which portions of the implant are loose, other areas of the implant may remain strongly integrated and resist removal. Further, there can be cases in which an implant fractures, leaving the residual portion of the implant in place without the interface for an extraction tool. Although the outcomes of revision osseointegration has not been the primary focus of any publication, the fact that revision can be necessary and generally succeeds in restoring similar mobility has been documented3-5. As with any hardware removal, preserving healthy tissue and avoiding iatrogenic injury are critically important. This article demonstrates several techniques to remove press-fit osseointegration implants that we have found safe and effective. Description: The procedure is performed with the patient in the supine position and with the affected extremity prepared and draped in a typical sterile fashion. The use of a tourniquet can help reduce blood loss, but it may be safer to not use a tourniquet during the portions of the procedure that create increased or prolonged bone thermal exposure, such as during reaming or drilling. If patients are clinically stable, withholding antibiotics until cultures are obtained may improve diagnostic yield. The implant removal technique should proceed from conservative to aggressive, as necessary: slap hammer, thin wire-assisted slap hammer, and extended osteotomy. Trephine reaming is discouraged because of the need for and difficulty of removing the dual cone interface portion of the implant, along with the extensive damage often caused to the surrounding bone during reaming, which can be avoided with the osteotomy technique. Alternatives: It is important to emphasize that most infections related to transcutaneous osseointegration do not require implant removal; the use of antibiotics alone or soft-tissue and/or limited bone debridement is sufficient to resolve infection in the majority of cases. If a patient has a non-infectious indication for removal (such as a loose implant) but declines surgery, activity modification with close observation may be reasonable. If a patient has an infectious indication for removal but declines surgery, very close observation must be maintained to avoid potential osteomyelitis. The use of suppressive antibiotics (oral and/or intravenous) may help reduce the severity of the infection. An alternative surgery to manage implant-associated infection can be amputation above the implant (within the same bone, through-joint amputation, or through the femur for a transtibial osseointegration). This should be considered only if there is a tremendously compelling reason to do so, such as an emergency need to amputate due to a life-threatening infection. Rationale: Indications for implant removal include persistent pain, deep infection recalcitrant to soft-tissue or bone debridement and implant retention, or mechanical complications involving the implant, such as loosening or breakage. The following are specific examples of indications for removal: infection that cannot be resolved with oral and/or intravenous antibiotics or with debridement of soft tissue and/or bone, implants that have not achieved or not maintained stable integration (aseptic or loosening) and are causing pain, and implants that have fractured or have deformed and are a concern for fracture. Expected Outcomes: Most patients who require removal of press-fit osseointegration implants are suitable for reimplantation after a decontamination period involving a local antibiotic depot and intravenous antibiotics. This duration is often 6 to 12 weeks. Following revision osseointegration, patients generally achieve similar levels of performance as they had during the stable period prior to removal3-5. Infection does not appear to be associated with an increased risk of mortality6. Patients who decline revision osseointegration are able to return to the use of a socket prosthesis. Important Tips: Infection is often treatable with use of oral and/or intravenous antibiotics, with or without soft-tissue and/or bone debridement. Consider these options before reflexively removing an implant.Preserving bone stock and quality is important for an optimal revision to another osseointegration prosthesis or conversion to a socket prosthesis. Living bone, even if infected, can be decontaminated with antibiotics. Minimize thermal injury by releasing the tourniquet and using saline solution irrigation during reaming or similar portions of the procedure. If the implant can only be removed by fully removing a portion of bone (rather than through a single clamshell-type osteotomy), attempt screw osteosynthesis to preserve a canal for future osseointegration.Be gentle and patient during the removal techniques. Elevating bone quickly or violently may cause propagating fractures, increased morbidity, or splinter bone fragments. Carefully separating bone from implant will reduce bone loss and preserve the bone condition for a potential revision.Although patients may not appear to have an infection in some cases, it is advised to treat every removal as if it involves an infection. The first surgical stage should be for removal, culture acquisition, and decontamination with antibiotics. A separate second surgery can be performed after the antibiotics have eradicated infection.Many implants have been removed with slap hammer or fine wire techniques; osteotomy should be reserved for situations in which diligent attempts using these techniques have proven unsuccessful, in order to optimize bone integrity.

Horrifying Basal Cell Carcinoma Presenting as Progressive Pyoderma Gangrenosum: Case Report.

Introduction: Skin ulcers can be challenging to diagnose and manage, particularly with comorbid autoimmune and gastrointestinal diseases. Occam's razor encourages the simplest explanation to guide care, but reconsideration must occur when intervention proves futile. Case Presentation: We report the case of a 70-year-old male, with a 17-year history of expanding pretibial skin ulcer, presumed by prior care providers to be pyoderma gangrenosum related to Crohn's disease. A surgical biopsy performed upon presentation to our institution revealed basal cell carcinoma of the skin, invasive to the proximal tibia with associated deep infection, prompting transfemoral amputation. Conclusion: This report is written as a reminder to reconsider a diagnosis and consider seeking additional expertise when a patient's condition progressively worsens despite intervention. Earlier diagnosis likely would have facilitated therapeutic limb salvage care.

Constructing an Osseointegrated Prosthetic Leg.

Background: Constructing an osseointegrated prosthetic leg is the necessary subsequent phase of care for patients following the surgical implantation of an osseointegrated prosthetic limb anchor. The surgeon implants the bone-anchored transcutaneous implant1,2 and the prosthetist constructs the prosthetic leg, which then attaches to the surgically implanted anchor. An osseointegration surgical procedure is usually considered in patients who are unable to use or are dissatisfied with the use of a socket prosthesis. Description: This present video article describes the techniques and principles involved in constructing a prosthetic leg for transfemoral and transtibial amputees, as well as postoperative patient care. Preoperatively, as part of a multidisciplinary team approach, the prosthetist should assist in patient evaluation to determine suitability for osseointegration surgery. Postoperatively, when approved by the surgeon, the first step is to perform an implant inspection and to take patient measurements. A temporary loading implant is provided to allow the patient to start loading the limb. When the patient is approved for full-length leg to begin full weight-bearing, the implant and prosthetic quality are evaluated, including torque, implant position, bench alignment, static alignment in the standing position, and initial dynamic alignment. This surgical procedure also requires long-term, continued patient care and prosthetic maintenance. Alternatives: For patients who are dissatisfied with the use of a socket prosthesis, adjustments can often be made to improve the comfort, fit, and performance of the prosthesis. Non-osseointegration surgical options include bone lengthening and/or soft-tissue contouring. Rationale: Osseointegration can be provided for amputees who are expressing dissatisfaction with their socket prosthesis, and typically provides superior mobility and quality of life compared with nonoperative and other operative options3,4. Specific differences between the appropriate design and construction of osseointegrated prostheses versus socket prostheses include component selection, component fit, patient-prosthesis static and dynamic alignment, tolerances and accommodations, and also the expected long-term changes in patient joint mobility and behavior. Providing an osseointegrated prosthesis according to the principles appropriate for socket prostheses may often leave an osseointegrated patient improperly aligned and provoke maladaptive accommodations, hindering performance and potentially putting patients at unnecessary risk for injury. Expected Outcomes: Review articles describing the clinical outcomes of osseointegration consistently suggest that patients with osseointegrated prostheses have improved prosthesis wear time, mobility, and quality of life compared with patients with socket prostheses. Importantly, studies have shown that osseointegrated prostheses can be utilized in patients with short residual limbs that preclude the use of a socket prosthesis, allowing them to regain or retain function of the joint proximal to the short residuum5,6. Osseoperception improves patient confidence during mobility7. Because there is an open skin portal, low-grade soft-tissue infection can occur, which is usually treated with a short course of oral antibiotics. Much less often, soft-tissue debridement or implant removal may be needed to treat infection8. Periprosthetic fractures can nearly always be treated with familiar fracture fixation techniques and implant retention9,10. Important Tips: Falls can lead to periprosthetic fractures.Malalignment can lead to unnecessary pathologic joint forces, soft-tissue contractures, and an accommodative gait.Inadequately sophisticated components can leave patients at a performance deficit.Wearing the prosthetic leg while sleeping may lead to rotational forces exerted on the limb, which may cause prolonged tension on the soft tissue. Acronyms and Abbreviations: QTFA = Questionnaire for Persons with a Transfemoral AmputationLD-SRS = Limb Deformity Modified Scoliosis Research SocietyPROMIS = Patient-Reported Outcomes Measurement Information SystemEQ-5D = EuroQol 5 Dimensions.

Transfemoral amputation versus knee arthrodesis for failed total knee replacement: A systematic review of outcomes.

BACKGROUND: The options available to salvage a failed total knee replacement (TKR) include transfemoral amputation (TFA) and knee arthrodesis (KA). This systematic review aims to evaluate outcomes following either TFA or KA, comparing ambulatory status, additional subsequent surgery, postoperative infection, pain, health-related quality of life (HRQoL), and mortality rate. METHODS: A literature search was conducted in EMBASE, Ovid Medline, and PubMed. Only primary research studies were included and data were independently extracted using a standardized form. The methodological quality of the studies was evaluated using Newcastle-Ottawa Scale. RESULTS: Forty-four papers were included, comprising 470 TFA and 1034 KA patients. The methodological quality of the studies was moderate. No TFA versus KA randomized controlled trials could be identified. Pooled data totals via subgroup analyses were performed, owing to inconsistent reporting methods in the included studies. Prosthesis use rate by TFA patients was 157/316 = 49.7%. Significant differences included that TFA patients had lower rates of ambulatory capacity than KA patients (139/294 = 45.6% versus 248/287 = 86.4%, p < 0.001), TFA ambulators were less likely to use an ambulatory aid (55/135 = 40.7% versus 167/232 = 72.0%, p < 0.001), and TFA was associated with a greater postoperative infection rate than KA (29/118 = 24.6% versus 129/650 = 17.2%, p = 0.054). There was a similar rate of revision surgery between TFA and KA (37/183 = 20.2% versus 145/780 = 18.6%, p = 0.612). Data on HRQoL for both TFA and KA were limited, contradictory, and heterogeneous. CONCLUSION: No randomized controlled trials comparing TFA versus KA exist;therefore, current data likely reflects substantial selection bias. The currently available evidence suggests that KA patients are significantly more likely to achieve independent bipedal ambulation than TFA patients. In both treatment cohorts, subsequent infection and revision surgery remain a relatively common occurrence.

Avoiding Compartment Syndrome, Vascular Injury, and Neurologic Deficit in Tibial Osteotomy: An Observational Study of 108 Limbs.

INTRODUCTION: Tibial deformities are common, but substantial concern may be associated with corrective osteotomy regarding major complications reported in classic literature. Such studies chiefly focused on high tibial osteotomy, with relatively little investigation of other areas and types of deformity. The primary aim of this study was to identify the rate of compartment syndrome, vascular injury, nerve injury, and other major complications after elective tibial osteotomy. METHODS: One hundred eight tibia osteotomies performed during 2019 to 2021 were evaluated, representing all tibia osteotomies except situations of existing infection. A retrospective chart review was performed to identify patient demographics, surgical indications, anatomic location of osteotomy, fixation used, and complications prompting additional surgery. RESULTS: The most common osteotomy locations were high tibial osteotomy (35/108 = 32%, 32/35 = 91% medial opening, and 3/35 = 9% medial closing), proximal metaphysis (30/108 = 28%), and diaphysis (32/108 = 30%). The most common fixation was plate and screw (38/108 = 35%) or dynamic frame (36/108 = 33%). Tranexamic acid was administered to 107/108 = 99% of patients and aspirin chemoprophylaxis was used for 83/108 = 86%. A total of 33/34= 97% of anterior compartment prophylactic fasciotomies were performed for diaphyseal or proximal metaphysis osteotomies. No events of compartment syndrome, vascular injury, nerve injury, or pulmonary embolism occurred. One patient required débridement to address infection. Additional surgery for delayed/nonunion occurred for nine segments (8%). Additional surgery for other reasons were performed for 10 segments (9%), none resulting in reduced limb function. CONCLUSION: Tibial osteotomy can be safely performed for a variety of indications in a diverse range of patients, without a notable risk of the most feared complications of compartment syndrome, vascular injury, and neurologic deficit. Prophylactic fasciotomy and reducing postoperative bleeding using tranexamic acid, along with location-specific safe surgical techniques, may help prevent major complications and thereby facilitate optimized deformity care.

Precice Stryde® Magnetic Internal Lengthening Nail does not Impair Bone Healing Despite Radiographic and Clinical Symptoms.

Aims: The Precice Stryde® internal magnetic lengthening nail allowed many patients a full weight-bearing experience during femur and tibia lengthening, but concerns over corrosion, pain and radiographic changes led to the implant's recall. Despite the recall, it is important to understand the rate of these occurrences and their influence on the overall success of the lengthening procedure. We aimed to investigate radiographic changes, patient-reported symptoms and bone healing indices for our cohort of Stryde lengthening. Materials and methods: Our surgical database and electronic medical record system were used to review and document patient demographics, indications for lengthening, length achieved, bone healing index (BHI), location and type of radiographic changes, time until radiographic changes were first visible, presence of pain symptoms (not attributable to surgery or distraction), time to implant removal and if the pain symptoms resolved following implant extraction. Results: From January 2019 to February 2021, 90 Stryde nails (78 femur and 12 tibia) were implanted in 63 patients. The cohort included 48 males and 15 females. The average length [± standard deviation (SD)] achieved was 58.4 ± 22.7 mm. The 66 bones (73%) developed radiographic changes and were found to be 58/78 (74%) femurs and 8/12 (67%) tibias. The average time to initial radiographic changes was 168 ± 108.1 days (femur) and 276 ± 126.8 days (tibia). Late-onset pain developed in 10 femur lengthening (11.1% of all nails) surgeries across eight patients (12.7% of all patients). All patients' pain resolved; three instances prior to nail removal and the remaining seven after nail removal. No patients were re-presented with worsening pain or radiographic changes following implant removal. Radiographic or symptomatic abnormalities did not impair bone formation. The BHI for femurs with (29.6 ± 16.6 days/cm, n = 58) vs without (29.4 ± 17.9 days/cm, n = 20) radiographic or symptomatic irregularity were nearly identical (p = 0.961). The difference between BHI for tibias with (39.3 ± 7.8 days/cm, n = 8) vs without (86.1 ± 38.2 days/cm, n = 4) radiographic changes was influenced by outliers and underpowered to draw a conclusion. Conclusion: Bone lengthening with the Stryde nail was associated with high rates of radiographic abnormalities, but symptoms were uncommon and resolved with explantation. The radiographic changes did not affect bone healing in the femur. Clinical significance: Radiographic changes including bone hypertrophy and osteolysis were common after bone lengthening with the Stryde nail, but the development of pain following consolidation was rare and resolved with implant removal.The BHI in femurs was not affected by radiographic changes. How to cite this article: Reif TJ, Geffner A, Hoellwarth JS, et al. Precice Stryde® Magnetic Internal Lengthening Nail does not Impair Bone Healing Despite Radiographic and Clinical Symptoms. Strategies Trauma Limb Reconstr 2023;18(2):94-99.

Comparative fixation devices for preventing migration of the proximal tibiofibular joint during tibial lengthening: a tether versus screw fixation.

BACKGROUND: When lengthening the tibia segment using motorized internal lengthening nails (MILN), undesired distal migration of the proximal fibula segment is prevented by tibiofibular stabilization, traditionally using a screw. A tightened cortical suspensory fixation rope (tether) is an alternative option, but its appropriateness has never been studied. The primary outcome was comparing the amount of proximal fibular migration between patients who were stabilized with either a tether or a screw. The secondary outcome was to evaluate the effect of fibular migration on the clinical outcome between both groups. METHODS: A retrospective study was conducted on patients who underwent tibial lengthening with MILN between April 2016 and June 2022. Two cohorts were compared: 18 limbs with tether fixation versus 29 limbs with screw fixation. Data on the patient's age, sex, etiologies, and clinical outcomes were collected. Radiographic measurements included the lengthening distance and the amount of proximal fibular migration. RESULTS: In total, 47 limbs from 41 patients, with average age 35.01 ± 13.72 years old. There were 28 males (68.29%) and 13 females (31.71%). The tether group demonstrated a statistically significant greater distance of migration than the screw group (p < 0.001), with an average migration distance of 8.39 ± 5.09 mm and 2.59 ± 3.06 mm, respectively. No correlation was found between the amount of tibial lengthening and the distance of proximal fibular migration in both the tether group (p = 0.96) and the screw group (p = 0.32). There was no significant difference in the change of knee extension between both groups (p = 0.3), and no patients reported knee pain or tightness. CONCLUSION: A screw provides better resistance to proximal tibiofibular joint migration during MILN lengthening, but the difference appears clinically inconsequential. Either option appears suitable.

Transcutaneous osseointegration for amputees with burn trauma.

OBJECTIVE: Transcutaneous osseointegration for amputees (TOFA) surgically implants a prosthetic anchor into the residual limb's bone, enabling direct skeletal connection to a prosthetic limb and eliminating the socket. TOFA has demonstrated significant mobility and quality of life benefits for most amputees, but concerns regarding its safety for patients with burned skin have limited its use. This is the first report of the use of TOFA for burned amputees. METHODS: Retrospective chart review was performed of five patients (eight limbs) with a history of burn trauma and subsequent osseointegration. The primary outcome was adverse events such as infection and additional surgery. Secondary outcomes included mobility and quality of life changes. RESULTS: The five patients (eight limbs) had an average follow-up time of 3.8 ± 1.7 (range 2.1-6.6) years. We found no issues of skin compatibility or pain associated with the TOFA implant. Three patients underwent subsequent surgical debridement, one of whom had both implants removed and eventually reimplanted. K-level mobility improved (K2 +, 0/5 vs 4/5). Other mobility and quality of life outcomes comparisons are limited by available data. CONCLUSION: TOFA is safe and compatible for amputees with a history of burn trauma. Rehabilitation capacity is influenced more by the patient's overall medical and physical capacity than their specific burn injury. Judicious use of TOFA for appropriately selected burn amputees seems safe and merited.

Association Between Osseointegration of Lower Extremity Amputation and Mortality Among Adults.

Importance: Transcutaneous osseointegration post amputation (TOPA) creates a direct linkage between residual bone and an external prosthetic limb, providing superior mobility and quality of life compared with a socket prosthesis. The causes and potential risks of mortality after TOPA have not been investigated. Objective: To investigate the association between TOPA and mortality and assess the potential risk factors. Design, Setting, and Participants: This observational cohort study included all patients with amputation of a lower extremity who underwent TOPA between November 1, 2010, and October 31, 2021, at a specialty orthopedic practice and tertiary referral hospital in a major urban center. Patients lived on several continents and were followed up as long as 10 years. Exposures: Transcutaneous osseointegration post amputation, consisting of a permanent intramedullary implant passed transcutaneously through a stoma and connected to an external prosthetic limb. Main Outcomes and Measures: Death due to any cause. The hypotheses tested-that patient variables (sex, age, level of amputation, postosseointegration infection, and amputation etiology) may be associated with subsequent mortality-were formulated after initial data collection identifying which patients had died. Results: A total of 485 patients were included in the analysis (345 men [71.1%] and 140 women [28.9%]), with a mean (SD) age at osseointegration of 49.1 (14.6) years among living patients or 61.2 (12.4) years among patients who had died. Nineteen patients (3.9%) died a mean (SD) of 2.2 (1.7) years (range, 58 days to 5 years) after osseointegration, including 17 (3.5%) who died of causes unrelated to osseointegration (most commonly cardiac issues) and 2 (0.4%) who died of direct osseointegration-related complications (infectious complications), of which 1 (0.2%) was coclassified as a preexisting health problem exacerbated by osseointegration (myocardial infarction after subsequent surgery to manage infection). No deaths occurred intraoperatively or during inpatient recuperation or acute recovery after index osseointegration (eg, cardiopulmonary events). Kaplan-Meier survival analysis with log-rank comparison and Cox proportional hazards regression modeling identified increased age (hazard ratio, 1.06 [95% CI, 1.02-1.09]) and vascular (odds ratio [OR], 4.73 [95% CI, 1.35-16.56]) or infectious (OR, 3.87 [95% CI, 1.31-11.40]) amputation etiology as risk factors. Notable factors not associated with mortality risk included postosseointegration infection and male sex. Conclusions and Relevance: These findings suggest that patients who have undergone TOPA rarely die of problems associated with the procedure but instead usually die of unrelated causes.

Unexpected positive intraoperative cultures (UPIC) at index osseointegration do not lead to increased postoperative infectious events.

Introduction: The most common complication following transcutaneous osseointegration for amputees is infection. Although an obvious source of contamination is the permanent stoma, operative site contamination at the time of implantation may be an additional source. This study investigates the impact of unexpected positive intraoperative cultures (UPIC) on postoperative infection. Methods: Charts were reviewed for 8 patients with UPIC and 22 patients with negative intraoperative cultures (NIC) who had at least 1 year of post-osseointegration follow-up. All patients had 24 h of routine postoperative antibiotic prophylaxis, with UPIC receiving additional antibiotics guided by culture results. The main outcome measure was postoperative infection intervention, which was graded as (0) none, (1) antibiotics unrelated to the initial surgery, (2) operative debridement with implant retention, or (3) implant removal. Results: The UPIC vs. NIC rate of infection management was as follows: Grade 0, 6/8 = 75 % vs. 14/22 = 64 %, p = 0.682; Grade 1, 2/8 = 25 % vs. 8/22 = 36.4 % (Fisher's p = 0.682); Grade 2, 1/8 = 12.5 % vs. 0/22 = 0 % (Fisher's p = 0.267); Grade 3, 0/8 = 0 % vs. 1/22 = 4.5 % (Fisher's p = 1.000). No differences were statistically significant. Conclusions: UPIC at index osseointegration, managed with directed postoperative antibiotics, does not appear to increase the risk of additional infection management. The therapeutic benefit of providing additional directed antibiotics versus no additional antibiotics following UPIC is unknown and did not appear to increase the risk of other adverse outcomes in our cohort.

Osseointegration Following Transfemoral Amputation After Infected Total Knee Replacement: A Case Series of 10 Patients With a Mean Follow-up of 5 Years.

Background: Management of total knee replacement (TKR) infection may sometimes prompt knee fusion (KF) or transfemoral amputation (TFA), both associated with low mobility and quality of life (QOL). Transcutaneous osseointegration for amputees provides superior mobility and QOL vs traditional socket prostheses but has not been studied for patients with a history of infected TKR. This study investigates the following hypothesis: Patients who have had TFA or KF following infected TKR achieve better mobility and QOL following transfemoral osseointegration. Material and methods: A retrospective evaluation of the prospectively maintained registry identified 10 patients who had prior infected TKR. The mobility assessments (patient daily prosthesis wear time, K-level, Timed Up and Go, 6-Minute Walk Test) and QOL surveys (Questionnaire for Persons with a Transfemoral Amputation Global, Mobility, and Problem scores) were compared preoperatively and after at least 2 years. Complications requiring an additional surgery were also evaluated. Results: Daily wear hours, K-level, and 6-Minute Walk Test and Questionnaire for Persons with a Transfemoral Amputation Global and Problem scores significantly improved (P < .05). Through 1 year, 4 patients (40%) had additional surgeries. After several years, 7 patients (70%) had at least 1 additional surgery, and 5 (50%) had multiple, for an average of 1 debridement and 1.3 soft-tissue refashionings per patient. One patient died of newly diagnosed cancer 1 year after transcutaneous osseointegration for amputees. Conclusion: Transfemoral osseointegration confers significantly better mobility and QOL vs KF or a TFA with traditional socket prostheses following infected TKR. Technique improvements to prevent subsequent surgeries may provide an increasingly streamlined experience.

The Clinical History and Basic Science Origins of Transcutaneous Osseointegration for Amputees.

Transcutaneous osseointegration for amputees (TOFA) refers to an intramedullary metal endoprosthesis which passes transcutaneously to connect with a limb exoprosthesis. The first recognizably modern experiments and attempts occurred in the 1940s. Multiple researchers using a plethora of materials and techniques over the following 50 years identified principles and obstacles which informed the first long-term successful surgery in 1990. Unfortunately, the current mainstream TOFA literature presents almost exclusively subsequent developments, generally omitting prior research, leading to some historical mistakes being repeated. Given the increasing interest and surgical volume of TOFA, this literature review was performed to delineate TOFA's basic science and surgical origins and to integrate these early efforts within the contemporary understanding. Studying this research could protect and benefit future patients, surgeons, and implant developers as TOFA is entering a phase of increased attention and innovation. The aim of this article is to provide a focused reference of foundational research, much of which is difficult to identify and retrieve, for clinicians and researchers.

Revision Amputation with Press-Fit Osseointegration for Transfemoral Amputees.

Press-fit transfemoral osseointegration is the technique of inserting an intramedullary metal implant into the residual femur of an amputee; the implant is passed transcutaneously to attach to a standard prosthesis that includes a knee, tibia, ankle, and foot. This allows the prosthesis to be skeletally anchored, eliminating socket-related problems such as tissue compression that can provoke neurogenic pain, skin abrasion, and fitting problems resulting from residual limb size fluctuation1. Amputees with osseointegrated prostheses typically wear their prosthesis more and experience better mobility, quality of life, and extremity proprioception compared to those with socket prostheses2-4. Description: We demonstrate the fundamentals of a single-stage procedure involving an impacted press-fit porous-coated titanium osseointegration implant. The preoperative evaluation is summarized and the specific surgical steps are described: exposure, osteotomy, canal preparation, implant insertion, (optional) targeted muscle reinnervation, muscle closure, soft-tissue contouring and stoma creation, and abutment insertion. Alternatives: Amputees who are dissatisfied with their quality of life or mobility when using a socket prosthesis can attempt to modify their socket or activity level or accept their situation. Non-osseointegration surgical options to try to improve socket fit include bone lengthening and/or soft-tissue contouring. An alternative design is a screw-type osseointegration implant1. Rationale: Press-fit osseointegration can be provided for amputees having difficulty with socket wear5. Press-fit osseointegration usually provides superior mobility and quality of life compared with nonoperative and other operative options for patients expressing dissatisfaction for reasons such as those mentioned above, including poor fit, compromised energy transfer, skin pinching, compression, and abrasions. Expected Outcomes: Review articles describing the clinical outcomes of osseointegration consistently suggest that patients have improved prosthesis wear time, mobility, and quality of life compared with patients with a socket prosthesis3,4. In a recent study2 of 18 femoral and 13 tibial amputees who had osseointegration, Reif et al. showed significant improvements in prosthesis wear time, mobility, and multiple quality-of-life surveys at a mean follow-up of nearly 2 years. The most common postoperative complication for this procedure is low-grade soft-tissue infection, which is usually managed by a short course of oral antibiotics. Much less often, soft-tissue debridement or implant removal may be needed to manage infection. Periprosthetic fractures can nearly always be managed with familiar fracture fixation techniques and implant retention6. Important Tips: Template and choose an implant with an optimal diameter that encroaches the inner cortex at the narrowest bone diameter; an implant that is too wide may not fit without causing a large fracture, and an implant that is too narrow may fall out. Do not cement the implant7.Ideally, the abutment of the implant should rest against a flat transverse bone end with cortical contact and leave the correct amount of room for the prosthetic knee so that it matches the height of the contralateral knee; avoid inserting an implant too distally or in too wide a metaphyseal flare.Gentle impaction pressure is necessary and small contained distal fractures are acceptable, but avoid causing a propagating fracture. Do not place cerclage cables or loose bone graft at these small fracture sites.Avoid the use of a tourniquet during intramedullary reaming to prevent potential heat-induced osteonecrosis.Nerve surgery such as targeted muscle reinnervation, if indicated, can be performed in the same surgical episode as the osseointegration.The muscles should be closed at the bone-implant interface with use of a tight purse string in order to provide a vascularized tissue barrier against bacterial ingress8.The skin surrounding the stoma should have unnecessary fat removed, but not excess removal leading to skin necrosis. The skin fascia should be sutured to the muscle surrounding the stoma to stabilize the peri-stomal skin.Soft-tissue contouring is needed to achieve the optimal soft-tissue tension around the stoma and abutment. Single-stage surgery has a distinct advantage in this regard. Acronyms and Abbreviations: MVA = motor vehicle accidentAP = anteroposteriorCT = computed tomographyTMR = targeted muscle reinnervationQTFA = Questionnaire for Persons with a Transfemoral AmputationEQ-5D = EuroQol 5 DimensionsLD-SRS = Limb Deformity-Scoliosis Research Society (questionnaire)PROMIS = Patient-Reported Outcomes Measurement Information System.

Lengthening the Lower Extremities of Children with Ollier's and Maffucci's Enchondromatosis Using Implantable Lengthening Nails.

There are multiple forms of enchondromatosis with Ollier's and Maffucci's being the most prevalent types. Limb length discrepancy is a common problem in patients with Ollier's and Maffucci's enchondromatosis. There are multiple reports about lengthening bones in patients with enchondromatosis using external fixators. However, there are no case series regarding the use of implantable lengthening technology. The purpose of this paper is to describe our experience with implantable nail lengthening in patients with enchondromatosis. A retrospective chart and radiographic review of patients with enchondromatosis who underwent implantable nail limb lengthening was performed. Seven patients with 14 bony segments were reviewed. A total of 11/14 lengthenings were completed without difficulty. There were no issues in terms of fixation location in patients with Ollier's disease. One patient with Maffucci's syndrome experienced migration of the nail during two lengthenings due to a combination of intralesional fixation and preconsolidation. One patient with Ollier's disease developed a knee extension contracture requiring manipulation under anesthesia. No other complications were recorded. The use of implantable nail lengthening to resolve limb length discrepancies in patients with Ollier's disease appears to be safe and effective.

Transtibial Osseointegration for Patients with Peripheral Vascular Disease: A Case Series of 6 Patients with Minimum 3-Year Follow-up.

The management of peripheral vascular disease (PVD) can require amputation. Osseointegration surgery is an emerging rehabilitation strategy for amputees. In this study, we report on 6 patients who had PVD requiring transtibial amputation (PVD-TTA) and either simultaneous or subsequent osseointegration (PVD-TTOI). METHODS: Six patients (aged 36 to 84 years) with transtibial amputation and preexisting PVD underwent osseointegration between 2014 and 2016 and were followed for 3 to 5 years. Pre- and postoperative clinical and functional outcomes (pain, prosthesis wear time, mobility, walking ability, and quality of life) and adverse events (infection, fracture, implant failure, revision surgery, additional amputation, and death) were prospectively recorded. RESULTS: All patients' mobility improved following osseointegration. Three patients initially had required the use of a wheelchair, precluding baseline walking tests; the other 3 were classified as K level 1 or 2, with mean baseline Timed Up and Go (TUG) test = 14.0 ± 2.2 s and 6-Minute Walk Test (6MWT) = 262 ± 75 m. At the time of the latest follow-up, all patients were K level 2 or 3; mean TUG = 12.7 ± 7.2 s and 6MWT = 353 ± 148 m. Four patients wore their prosthesis ≥16 hours daily. Three patients had superficial soft-tissue infections. One other patient experienced recurrent infections 2.8 years after osseointegration requiring debridements and transfemoral amputation; the patient died 2 days following surgery from myocardial infarction caused by coronary atherosclerosis. CONCLUSIONS: All 6 patients who underwent PVD-TTOI in this case series survived through 2 years. Patients who initially had used a wheelchair achieved and maintained independent, unaided ambulation until PVD-related impairments in the contralateral leg occurred in 1 patient. Patients previously using a traditional socket prosthesis reported improvement in mobility and quality of life. One patient's death underscores the importance of careful patient selection. However, marked improvement in the other 5 patients suggests cautious optimism that PVD-TTA is not an absolute osseointegration contraindication. Conscientious further investigation seems appropriate. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study.

INTRODUCTION: Lower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. METHODS AND ANALYSIS: This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. ETHICS AND DISSEMINATION: The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences.

Evaluating the reoperation rate and hardware durability of three stabilizing implants for 105 malignant pathologic humerus fractures.

INTRODUCTION: Many patients sustaining a malignant pathologic humerus fracture (MPHF) elect for surgical stabilization. Complications prompting reoperation can occur, leading to additional quality of life and financial cost. One common event preceding reoperation is a broken implant (BI). The purpose of this study was to identify the rate of reoperation following surgical stabilization of MPHF with three techniques - photodynamic bone stabilization (PBS), intramedullary nail (IMN), and cemented plate fixation (CPF) - and estimate to what extent improved implant durability might prevent reoperation. MATERIALS AND METHODS: Retrospective data collection was performed, identifying 105 procedures (100 patients) who underwent non-articular MPHF surgery from 2010-2016: 19 PBS, 65 IMN, 21 CPF. All patients were followed for at least two years or until death. RESULTS: Reoperation rates were similar at one year (10.5%,6.2%,4.8%, p = 737), two years (15.8%,6.2%,9.5%, p = 375), and final evaluation (15.8%,7.7%,14.3%, p = 248). The rate of BI for PBS, IMN, and CPF was 10.5%,0%, and 4.8% (p = 049 PBS/IMN) at one year, 15.8%,0%, and 9.5% (p = 010 PBS/IMN) at two years, and 15.8%,0%, and 14.3% (p = 010 IMN/PBS, p = 013 IMN/CPF) at final evaluation. CONCLUSIONS: Reoperation rate was not significantly different at any time point. However, IMN surgery resulted in the lowest rate of broken implants (zero), statistically significant versus PBS at all time periods and versus CPF at final follow-up. PBS may eventually offer selected advantages for MPHF management, but current data suggests fragility must be thoughtfully considered.