Osseointegrated Prosthetic Limb for the treatment of lower limb amputations : Experience and outcomes.

BACKGROUND: Osseointegration has emerged over the past two decades as a dramatically different approach for the treatment of lower limb amputations, which involves direct attachment of the prosthesis to the skeletal residuum. This approach can address many of the socket-interface issues associated with socket prostheses which represent the current standard of care for amputees. The Osseointegrated Prosthetic Limb (OPL) is an osseointegration implant with a new design and improved features compared to other available implant systems. OBJECTIVES: To report on the experience and outcomes of using the OPL for osseointegrated reconstruction of lower limb amputations. MATERIALS AND METHODS: This is a retrospective study of 22 patients who received the OPL implant between December 2013 and November 2014. Clinical outcomes were obtained pre- and post-operatively, with results reported at the 1­year follow-up. Outcome measures included the Questionnaire for persons with a Trans-Femoral Amputation (Q-TFA), Short Form Health Survey 36 (SF-36), Six-Minute Walk Test (6MWT), and Timed Up and Go (TUG). Adverse events were also recorded. RESULTS: Compared to the mean pre-operative values obtained while patients were using socket prostheses or were wheelchair-bound, the mean post-operative values for all four validated outcome measures were significantly improved. There were 15 episodes of minor infections in 12 patients, all of which responded to antibiotics. Soft tissue refashioning was performed electively on 6 patients. No other adverse events were recorded. CONCLUSIONS: The results demonstrate that osseointegration surgery using the OPL is a relatively safe and effective procedure for the reconstruction and rehabilitation of lower limb amputees.

19 years outcome after cementless total hip arthroplasty with spongy metal structured implants in patients younger than 65 years.

BACKGROUND: Cementless fixation of total hip arthroplasties (THAs) is often favored in young, high-demanding patients due to the conservation of valuable bone-stock and easier revision if loosening has occurred. Long-term outcome data of the spongy metal structured implant used in the present study in patients younger than 65 years are still lacking. METHODS: We conducted a retrospective chart review and functional investigation (Merle d'Aubigné score, SF-12) of patients younger than 65 years at implantation treated with a spongy metal structured THA (n = 79) from one orthopedic university center from 1985 to 1989. RESULTS: At a 19-year mean follow-up (range: 15.3 - 21.3 years), the overall stem survival rate was 93.7 %, and the overall cup survival rate was 82.3 %. Revision surgeries of the stem were performed in all cases for aseptic loosening at an average of 15.3 ± 3.5 years after implantation. Acetabular components were revised for aseptic loosening and recurrent dislocation after inlay revision on an average of 11.8 ± 4.7 years after implantation. No other device related complications occurred within the 19-year follow-up period. No correlation was found between time of revision and gender or age. Clinical outcome scores (Merle d'Aubigné score, SF-12) revealed excellent to good results of the implanted THAs in 87 % of patients. CONCLUSIONS: We conclude that spongy metal structured cementless THAs implanted in young patients have an excellent survival and provide trustworthy clinical results at 19 years of follow-up.

Osseointegrated total knee replacement connected to a lower limb prosthesis: 4 cases.

BACKGROUND AND PURPOSE: Osseointegrated implants are an alternative for prosthetic attachment in individuals with amputation who are unable to wear a socket. However, the load transmitted through the osseointegrated fixation to the residual tibia and knee joint can be unbearable for those with transtibial amputation and knee arthritis. We report on the feasibility of combining total knee replacement (TKR) with an osseointegrated implant for prosthetic attachment. PATIENTS AND METHODS: We retrospectively reviewed all 4 cases (aged 38-77 years) of transtibial amputations managed with osseointegration and TKR in 2012-2014. The below-the-knee prosthesis was connected to the tibial base plate of a TKR, enabling the tibial residuum and knee joint to act as weight-sharing structures. A 2-stage procedure involved connecting a standard hinged TKR to custom-made implants and creation of a skin-implant interface. Clinical outcomes were assessed at baseline and after 1-3 years of follow-up using standard measures of health-related quality of life, ambulation, and activity level including the questionnaire for transfemoral amputees (Q-TFA) and the 6-minute walk test. RESULTS: There were no major complications, and there was 1 case of superficial infection. All patients showed improved clinical outcomes, with a Q-TFA improvement range of 29-52 and a 6-minute walk test improvement range of 37-84 meters. INTERPRETATION: It is possible to combine TKR with osseointegrated implants.

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.

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.

Development of an evidence-based diagnostic algorithm for infection in patients with transcutaneous osseointegration following amputation.

Introduction: Transcutaneous osseointegration following amputation (TOFA) confers better mobility and quality of life for most patients versus socket prosthesis rehabilitation. Peri-TOFA infection remains the most frequent complication and lacks an evidence-based diagnostic algorithm. This study's objective was to investigate preoperative factors associated with positive intraoperative cultures among patients suspected of having peri-TOFA infection in order to create an evidence-based diagnostic algorithm. Methods: We conducted a retrospective study of 83 surgeries (70 patients) performed to manage suspected lower-extremity peri-TOFA infection at a specialty orthopedic practice and tertiary referral hospital in a major urban center. The diagnosis of infection was defined as positive intraoperative cultures. Preoperative patient history (fevers, subjective pain, increased drainage), physician examination findings (local cellulitis, purulent discharge, implant looseness), and laboratory data (white blood cell count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and external swab culture) were evaluated for association with subsequent positive intraoperative cultures using regression and area under receiver-operator curve (AUC) modeling. Results: Peri-implant limb pain (highly correlated with infection), ESR >30 (highly correlated against infection), positive preoperative swab (moderately correlated with infection), gross implant motion (moderately correlated against infection), and erythema or cellulitis of the transcutaneous region (mildly correlated with infection) were variables included in the best AUC model, which achieved an 85 % positive predictive value. Other clinical findings and laboratory values (notably CRP and WBC) were non-predictive of infection. Conclusions: This seminal investigation to develop a preoperative diagnostic algorithm for peri-TOFA infection suggests that the clinical examination remains paramount. Further evaluation of a wider spectrum of clinical, laboratory, and imaging data, consistently and routinely collected with prospective data techniques in larger cohorts of patients, is necessary to create a robust predictive algorithm.

The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study.

BACKGROUND: The Vega System® PS (Aesculap AG, Tuttlingen, Germany) is an advanced, third generation fixed implant that aims to mimic natural knee kinematics by optimizing pivotal motion while reducing surface stress. This study evaluated mid-term survival and clinical outcomes, including range of motion (ROM) of the modern posterior stabilized implant in order to analyse whether this biomechanically successful implant reaches good results in situ. METHODS: The first 100 patients to receive the Vega PS System for total knee arthroplasty were invited to take part in this single centre, single surgeon study. Of these, 84 patients were clinically assessed 5-6 years postoperatively. Data which was obtained during this follow-up examination included revision data, range of motion and clinical scores. RESULTS: The 5-year survival rate for exchange of any component was 97.6%, whereby two patients required replacement of the polyethylene gliding surface. Secondary patella resurfacing was performed in 7 patients. Significantly improved results in comparison to the preoperative state could be obtained at the follow-up: KOOS improved from 39.4 to 78.8, SF-12 PCS improved from 32.1 to 42 SF-12 MCS improved from 46 to 53.8 and patella pain improved from 2.7 to 0.3. The mean ROM of the 84 patients after 5 years was 133.1° and mean total KSS was 189.9. DISCUSSION & CONCLUSIONS: This study demonstrates a high survival rate of the Vega PS System® and significant improvements in clinical outcomes 5 years after implantation. The obtained mean ROM indicates that this implant provides good flexibility of the knee joint, allowing a high number of activities. However, due to the rate of secondary patella implantation, routine resurfacing of the patella for all PS TKA cases is highly recommended. CLINICAL TRIALS REGISTRATION: The study was registered at clinicaltrials.gov (NCT02802085).

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.

Bone mineral density in osseointegration implant surgery: A review of current studies (Review).

Osseointegration implant (OI) surgery is the latest rehabilitation technology for amputees, where a bone-anchored implant obviates the limitations of traditional socket prostheses. The bone mineral density (BMD) in the periprosthetic and other anatomical regions can be used to assess bone remodelling following OI surgery. Currently, limited studies have used BMD measurements in reporting post-operative OI outcomes and the association between the maintenance of BMD and implant efficacy has remained elusive. This review captured and analysed all studies that have reported the BMD as an objective outcome measure in patients with trans-femoral or trans-tibial OI. The PubMed, Medline, Scopus and Web of Science databases were searched using the terms 'amputation', 'osseointegration' and 'bone mineral density'. A total of 6 studies involving human participants were included for analysis. All studies used dual X-ray absorptiometry and/or X-rays for measuring BMD. Rehabilitation of trans-femoral or trans-tibial amputation using OI may help restore healthy BMD by enabling physiological bone loading. However, there is a low correlation between the BMD around the OI and the success of OI surgery or the risk of periprosthetic fractures. This review summarises the current evidence on BMD assessment in OI for lower limb amputee rehabilitation. Despite the great variability in the results, the available evidence suggests that OI may help restore BMD following surgery. The limited evidence calls for further investigation, as well as the development of a standard BMD measurement protocol.

The safety of one-stage versus two-stage approach to osseointegrated prosthesis for limb amputation.

Aims: Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. Methods: A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications. Results: A total of 19 studies were included: four one-stage, 14 two-stage, and one article with both one- and two-stage groups. Superficial infection was the most common complication (one-stage: 38% vs two-stage: 52%). There was a notable difference in the incidence of osteomyelitis (one-stage: nil vs two-stage: 10%) and implant failure (one-stage: 1% vs two-stage: 9%). Fracture incidence was equivocal (one-stage: 13% vs two-stage: 12%), and comparison of soft-tissue, stoma, and mechanical related complications was not possible. Conclusion: This review suggests that the one-stage approach is favourable compared to the two-stage, because the incidence of complications was slightly lower in the one-stage cohort, with a pertinent difference in the incidence of osteomyelitis and implant failure.

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.

Bone density changes after five or more years of unilateral lower extremity osseointegration: Observational cohort study.

Context: Rehabilitation following lower extremity amputation presents multiple challenges, many related to the traditional prosthesis (TP) socket. Without skeletal loading, bone density also rapidly decreases. Transcutaneous osseointegration for amputees (TOFA) surgically implants a metal prosthesis attachment directly into the residual bone, facilitating direct skeletal loading. Quality of life and mobility are consistently reported to be significantly superior with TOFA than TP. Objective: To investigate how femoral neck bone mineral density (BMD, g/cm2) changes for unilateral transfemoral and transtibial amputees at least five years following single-stage press-fit osseointegration. Methods: Registry review was performed of five transfemoral and four transtibial unilateral amputees who had dual x-ray absorptiometry (DXA) performed preoperatively and after at least five years. The average BMD was compared using Student's t-test (significance p < .05). First, all nine Amputated versus Intact limbs. Second, the five patients with local disuse osteoporosis (ipsilateral femoral neck T-score < -2.5) versus the four whose T-score was greater than -2.5. Results: The average Amputated Limb BMD was significantly less than the Intact Limb, both Before Osseointegration (0.658 ± 0.150 vs 0.929 ± 0.089, p < .001) and After Osseointegration (0.720 ± 0.096 vs 0.853 ± 0.116, p = .018). The Intact Limb BMD decreased significantly during the study period (0.929 ± 0.089 to 0.853 ± 0.116, p = .020), while the Amputated Limb BMD increased a not statistically significant amount (0.658 ± 0.150 to 0.720 ± 0.096, p = .347). By coincidence, all transfemoral amputees had local disuse osteoporosis (BMD 0.545 ± 0.066), and all transtibial patients did not (BMD 0.800 ± 0.081, p = .003). The local disuse osteoporosis cohort eventually had a greater average BMD (not statistically significant) than the cohort without local disuse osteoporosis (0.739 ± 0.100 vs 0.697 ± 0.101, p = .556). Conclusions: Single-stage press-fit TOFA may facilitate significant BMD improvement to unilateral lower extremity amputees with local disuse osteoporosis.

Comparison of prosthetic mobility and balance in transfemoral amputees with bone-anchored prosthesis vs. socket prosthesis.

BACKGROUND: The literature comparing bone-anchored prosthesis (BAP) with socket prosthesis (SP) consistently reports improvement in physical health and quality of life using primarily patient-reported outcome measures (PROMs). OBJECTIVE: To determine the differences in mobility and balance using performance-based outcome measures and PROMs in people with transfemoral amputations (TFAs) fitted with BAP vs. SP. STUDY DESIGN: Causal comparative. METHODS: Two groups of people with TFAs were recruited: one using a BAP (N = 11; mean age ± standard deviation, 44 ± 14.9 years; mean residual limb length as a percentage of the intact femur, 68% ± 15.9) and another group using a SP (N = 11; mean age ± standard deviation, 49.6 ± 16.0 years; mean residual limb length as a percentage of the intact femur, 81% ± 13.9), and completed the 10-meter walk test, component timed-up-and-go, Prosthetic Limb Users Survey of Mobility™ 12-item, and Activities-specific Balance Confidence Scale. RESULTS: There were no statistically significant differences between the BAP and SP groups in temporal spatial gait parameters and prosthetic mobility as measured by the 10-meter walk test and component timed-up-and-go, yet large effect sizes were found for several variables. In addition, Activities-specific Balance Confidence Scale and Prosthetic Limb Users Survey of Mobility™ scores were not statistically different between the BAP and SP groups, yet a large effect sizes were found for both variables. CONCLUSIONS: This study found that people with TFA who use a BAP can demonstrate similar temporal spatial gait parameters and prosthetic mobility, as well as self-perceived balance confidence and prosthetic mobility as SP users. Therefore, suggesting that the osseointegration reconstruction surgical procedure provides an alternative option for a specific population with TFA who cannot wear nor have limitations with a SP. Future research with a larger sample and other performance-based outcome measures and PROMs of prosthetic mobility and balance would further determine the differences between the prosthetic options.

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.

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.

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.

Amputation With Osseointegration for Patients With Intractable Complex Regional Pain Syndrome: A Report of 3 Cases.

CASES: Three patients with knee-level complex regional pain syndrome type 1 (CRPS1), recalcitrant to conservative interventions, elected for transfemoral amputation and osseointegration. Two patients gained independent ambulation; the third remains on crutches after a disrupted sciatic nerve targeted reinnervation. One uses no pain medication, one is weaning off, and one requires a reduced regimen after revision nerve innervation. CONCLUSION: Osseointegration seems suitable to optimize rehabilitation after amputation for CRPS1.

Pelvic Osseointegration for Unilateral Hip Disarticulation: A Case Report.

CASE: A 24-year-old man with right unilateral hip disarticulation, intolerant of a traditional socket-mounted prosthesis (TSP), underwent pelvic transcutaneous osseointegration and was fit with a prosthetic lower extremity 7 months later. Twenty-four months after osseointegration, he remains pain-free and complication-free, wears his prosthesis all waking hours, walks without assistive devices and can carry 2-handed objects, and works as a livestock farmer. CONCLUSION: Through 24 months, the world's first patient with pelvic osseointegration has no complications and better mobility than most patients with unilateral hip disarticulation using TSPs. Pelvic osseointegration seems reasonable to further consider in carefully selected patients.

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.

Cementing Osseointegration Implants Results in Loosening: Case Report and Review of Literature.

Skeletal transcutaneous osseointegration was performed on a 54-year-old female transfemoral amputee. None of the available osseointegration implants achieved press-fit stability, so an implant was cemented in position. Although initially stable, by six months the patient reported painful loading and radiographs revealed cement mantle lucency. The osseointegration implant was removed, antibiotics were delivered via implanted spacer and intravenously, and revision osseointegration three months later achieved appropriate immediate press-fit stability. Cemented transcutaneous osseointegration implants loosen within one year. Osseointegration is only successful when bone grows directly onto the implant.