The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study.

OBJECTIVE: Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DESIGN: Single-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SETTING: Veterans Health Administration Hospital. PARTICIPANTS: Ten male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). INTERVENTIONS: All participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. OUTCOME MEASURES: Adverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. RESULTS: Ten male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. CONCLUSIONS: Improvements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.

What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?

BACKGROUND: Septic loosening and stem breakage due to metal fatigue is a rare but well-known cause of orthopaedic implant failure. This may also affect the components of the osseointegrated implant system for individuals with transfemoral amputation who subsequently undergo revision. Identifying risk factors is important to minimize the frequency of revision surgery after implant breakage. QUESTIONS/PURPOSES: (1) What proportion of patients who received an osseointegrated implant after transfemoral amputation underwent revision surgery, and what were the causes of those revisions? (2) What factors were associated with revision surgery when stratified by the location of the mechanical failure and (septic) loosening (intramedullary stem versus dual cone adapter)? METHODS: Between May 2009 and July 2015, we treated 72 patients with an osseointegrated implant. Inclusion criteria were a minimum follow-up of 5-years and a standard press-fit cobalt-chromium-molybdenum (CoCrMb) transfemoral osseointegrated implant. Based on that, 83% (60 of 72) of patients were eligible; a further 3% (2 of 60) were excluded because of no received informed consent (n = 1) and loss to follow-up (n = 1). Eventually, we included 81% (58 of 72) of patients for analysis in this retrospective, comparative study. We compared patient characteristics (gender, age, and BMI), implant details (diameter of the intramedullary stem, length of the dual cone, and implant survival time), and event characteristics (infectious complications and distal bone resorption). The data were retrieved from our electronic patient file and from our cloud-based database and analyzed by individuals not involved in patient care. Failures were categorized as: (1) mechanical failures, defined as breakage of the intramedullary stem or dual-cone adapter, or (2) (septic) loosening of the osseointegrated implant. RESULTS: Thirty-four percent (20 of 58) of patients had revision surgery. In 12% (7 of 58) of patients, the reason for revision was due to intramedullary stem failures (six breakages, one septic loosening), and in 22% (13 of 58) of patients it was due to dual-cone adaptor failure (10 weak-point breakages and four distal taper breakages; one patient broke both the weak-point and the dual-cone adapter). Smaller median stem diameter (failure: 15 mm [interquartile range 1.3], nonfailure: 17 mm [IQR 2.0], difference of medians 2 mm; p < 0.01) and higher median number of infectious events (failure: 6 [IQR 11], nonfailure: 1 [IQR 3.0], difference of medians -5; p < 0.01) were associated with revision intramedullary stem surgery. No risk factors could be identified for broken dual-cone adapters. CONCLUSION: Possible risk factors for system failure of this osteointegration implant include small stem diameter and high number of infectious events. We did not find factors associated with dual-cone adapter weak-point failure and distal taper failure, most likely because of the small sample size. When treating a person with a lower-limb amputation with a CoCrMb osseointegrated implant, we recommend avoiding a small stem diameter. Further research with longer follow-up is needed to study the success of revised patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Greater early migration of a short-stem total hip arthroplasty is not associated with an increased risk of osseointegration failure: 5th-year results from a prospective RSA study with 39 patients, a follow-up study.

Background and purpose - Short-stem hip arthroplasty has been a viable alternative to standard stems for the treatment of hip osteoarthritis for over 10 years. This study assessed whether a correlation existed between a greater initial increase in implant migration and inferior clinical outcomes at 5 years postoperatively. Results on these patients after 2 years have been published previously.Patients and methods - Radiostereometry and clinical scoring were undertaken after surgery and at 3, 6, 12, and 24 months, and 5 years postoperatively. The migration and the clinical outcomes data from the patients with initial migrations at 3 months above the 75th percentile (≥ 75% group) were compared with those with migrations at 3 months of less than the 75th percentile (< 75% group).Results - Between 3 months and 5 years after surgery, the mean resultant implant migrations were 0.40 mm (SD 0.32) in the ≥ 75% group and 0.39 mm (SD 0.25) in the < 75% group. The mean Harris Hip Scores and SF-36 physical scores at 5 years postoperatively were 100 (SD 0.4) and 44 (SD 12), respectively, for the ≥ 75% group and 99 (SD 2) and 50 (SD 10), respectively, for the < 75% group. The differences between the patient groups were not statistically significant.Interpretation - There was no correlation between a greater initial migration and inferior clinical outcomes at 5 years postoperatively. Despite a greater initial migration, there were no risks of early aseptic loosening and inferior midterm clinical outcomes associated with a short-stem implant with a primary metaphyseal anchorage.

Histopathological Evaluation of Orthopedic Medical Devices: The State-of-the-art in Animal Models, Imaging, and Histomorphometry Techniques.

Orthopedic medical devices are continuously evolving for the latest clinical indications in craniomaxillofacial, spine, trauma, joint arthroplasty, sports medicine, and soft tissue regeneration fields, with a variety of materials from new metallic alloys and ceramics to composite polymers, bioresorbables, or surface-treated implants. There is great need for qualified medical device pathologists to evaluate these next generation biomaterials, with improved biocompatibility and bioactivity for orthopedic applications, and a broad range of knowledge is required to stay abreast of this ever-changing field. Orthopedic implants require specialized imaging and processing techniques to fully evaluate the bone-implant interface, and the pathologist plays an important role in determining the proper combination of histologic processing and staining for quality slide production based on research and development trials and validation. Additionally, histomorphometry is an essential part of the analysis to quantify tissue integration and residual biomaterials. In this article, an overview of orthopedic implants and animal models, as well as pertinent insights for tissue collection, imaging, processing, and slide generation will be provided with a special focus on histopathology and histomorphometry evaluation.

Complications after radial head arthroplasty: a comparison between short-stemmed bipolar and monopolar long-stemmed osteointegrative rigidly fixed prostheses.

INTRODUCTION: To date, only a few studies have compared radial head prostheses (RHP) and their different anchoring principles. The aim of this study was to characterize concomitant injuries, necessary adjuvant procedures, complications, and radiological findings after implantation of two different types of RHP. METHODS: Sixty-six patients with radial head fractures were treated with MoPyC (Tornier/France, 50 mm stem, monopolar) or SBI rHead prostheses (Small Bone Innovations/USA, 22-mm stem, bipolar) and followed up over 42 months (16-64 months). Primary objective was the detection of different loosening and explantation rates. In addition to the revision rate and the reasons for revision, we also used radiological findings to assess the dynamics of lysis phenomena. RESULTS: Thirty-five patients (mean age 48 years; 22-73 years) were treated with the MoPyC, and 31 patients (mean age 47 years, 19-69 years) with the rHead prosthesis. Of these, 98% had a Mason 3 or 4 type of radial head fracture, and 94% showed concomitant injuries, which were addressed in 89% of cases by adjuvant procedures. The surgical revision rate was 20% (rHead 23%; MoPyC 18%). Significantly more of the rHead prostheses had to be explanted compared to MoPyC prostheses because of painful loosening (16% vs. 3%; p = 0.029). Predictors of subsequent loosening were significant radiolucent lines in the RHP over the first six months and an increase in width by two and a half times within the first 50 days after implantation. CONCLUSION: Complex radial head fractures are frequent and difficult to treat. The monopolar long-stemmed prosthesis showed significantly lower rates of painful loosening and explanation rates than the bipolar short-stemmed prosthesis.

Endplate changes after lumbar discectomy with and without implantation of an annular closure device.

BACKGROUND: The implantation of a bone-anchored annular closure device (ACD) might be associated with the developed new endplate changes (EPC) after surgery. METHODS: A post hoc analysis has been done in patients from a prospective randomized multicenter study. All patients underwent limited lumbar discectomy with intraoperative randomization into the groups limited lumbar discectomy alone or additional ACD implantation. Low-dose lumbar computed tomography (CT) and clinical investigations were performed preoperatively and 12 months after the operation. RESULTS: A total of 554 patients were randomized. After exclusion of dropouts, the per-protocol population included 493 patients (251 in the control group and 242 in the ACD group); the follow-up rate was ≥ 90%. The number of patients showing EPC at baseline was similar in both groups. The number of patients showing EPC and the total EPC lesion area significantly increased in both groups over time, but significantly increased more in the EPC group for the superior and inferior endplate (all P < 0.0001). There was no association of pre-existing number and size of EPC with sex, age, or smoking habits. Correlation of clinical variables showed no relation with number, size, and increase of EPC area after surgery. CONCLUSIONS: Patients with primary lumbar disc herniation show EPC in the corresponding segments. There is a significant increase of lesion number and size within 12 months after discectomy. This increase is significantly more pronounced in the ACD group. Presence and growth of EPC is not correlated with low-back pain or ODI.

Percutaneous Bone-Anchored Hearing Implant Surgery: Do Syndromic Children Have More Adverse Perioperative Outcomes?

OBJECTIVE: To evaluate and compare perioperative outcomes of percutaneous bone-anchored hearing implant (BAHI) surgery in syndromic and nonsyndromic pediatric patients. STUDY DESIGN: Retrospective cohort study. SETTING: McGill University Health Centre in Montreal, Quebec, Canada. PATIENTS: Forty-one pediatric patients (22 syndromic, 19 nonsyndromic) who underwent percutaneous BAHI surgery between March 2008 and April 2021. INTERVENTION: Percutaneous BAHI surgery. MAIN OUTCOME MEASURES: Patient demographics (age at surgery, gender, implant laterality), operative information (American Society of Anesthesia [ASA] score, anesthesia type, surgical technique, implant/abutment characteristics), and postoperative outcomes (implant stability, soft tissue integrity, surgical revisions, implant failure). RESULTS: The most frequent syndromes among implanted patients were Treacher Collins (27.3%), Goldenhar (13.6%), Trisomy 21 (13.6%), and Nager (9.1%). Syndromic patients were more frequently given higher ASA scores: 2 ( p = 0.003) and 3 ( p = 0.014). All cases of implant extrusion were in syndromic patients: two posttraumatic and two failures to osseointegrate. Nine (40.9%) syndromic patients experienced a Holgers Grade 4 skin reaction at one of their postoperative follow-up visits as compared to 0% of nonsyndromic patients ( p < 0.001). Implant stability was similar between cohorts at all postoperative time-points, except for significantly greater nonsyndromic implant stability quotient scores at 16 weeks ( p = 0.027) and 31+ weeks ( p = 0.016). CONCLUSIONS: Percutaneous BAHI surgery is a successful rehabilitation option in syndromic patients. However, it presents a relatively higher incidence of implant extrusion and severe postoperative skin reactions as compared to nonsyndromic patients. In light of these findings, syndromic patients may be great candidates for novel transcutaneous bone conduction implants.

Single-Center Experience Evaluating Clinical Outcomes of a Novel-Guided Drill System for Percutaneous Bone-Anchored Hearing Implant.

OBJECTIVE: Evaluate intraoperative and postoperative outcomes of a novel guided drill system for percutaneous bone-anchored hearing implants. METHODS: Between January 2016 and February 2021, patients age ≥18 years deemed potential candidates for a bone-anchored hearing device, were formally assessed for candidacy and counseling. Those that qualified and opted to proceed were added to a prospectively maintained database, including demographic, clinical, and audiologic data. Intraoperative findings were reported, as were clinical outcomes at 7 days, 4 weeks, 3 months and 6 months postoperatively. The Holgers index was used to grade soft tissue reactions. RESULTS: One hundred patients underwent the procedure. There were 56 women, and mean age was 54 years (18-84 yr). Ninety-six were done under local anesthetic. Mean surgical time was 13 minutes (9-27 min). No significant intraoperative events were noted. There were nine cases of implant loss, all in the first 50 cases. Mean duration of implant loss was 3.6 weeks (range, 2-5 wk). At the first postoperative visit, 82 had Holgers 0, 16 Holgers 1, 2 Holgers 2, and none Holgers 3. At the second postoperative visit, excluding the 9 with implant loss, 83 (91%) had Holgers 0, 6 (7%) Holgers 1, and 2 (2%) Holgers 2. None were Holgers 3. CONCLUSIONS: The current study represents, to our knowledge, the largest series on the novel guided drill technique. Results show it is safe and efficient with low soft tissue complication rates. Drill bit design and technical modifications may have helped lower implant loss rate in this series over time.

Novel Surgical Technique in Active Bone Conduction: Minimally Invasive Approach to Fully Implantable Osseointegrated Implant.

We report our experience using a novel minimally invasive surgical technique for implantation of a fully implantable active bone conduction implant. This was a retrospective review of 16 adults, including 10 women and 6 men. The mean age was 54 years. Hearing loss profiles included 8 with mixed hearing loss, 5 with conductive hearing loss, and 3 with single-sided deafness. Nine patients underwent placement through the standard approach and 7 with the minimally invasive approach. There were no postoperative complications at a mean follow-up of 6.5 months (SD, 4; range, 1.5-12), and all patients received audiologic benefit with objective improvement in sound-field thresholds upon activation. Mean operative time was shorter with the minimally invasive approach (64 vs 41 minutes, P = .01). The fully implantable bone-anchored auditory implant can be effectively placed via a minimally invasive incision, with potential benefits of decreased operative time, low risk for intra- and postoperative complications, and rapid healing.

The efficacy of bone-anchored hearing implant surgery in children: A systematic review.

OBJECTIVE: To evaluate the efficacy of Bone-Anchored Hearing implants (BAHIs) in children and to elucidate the usage and outcomes of new surgical techniques and implants in this specific population. DATA SOURCES: Embase and PubMed. STUDY SELECTION: We identified studies evaluating surgical outcomes of BAHIs in children. Retrieved articles were screened using predefined inclusion and exclusion criteria. Critical appraisal included directness of evidence and risk of bias. Studies that successfully passed critical appraisal were included. DATA EXTRACTION: Outcome measures included patient demographics, follow-up time, surgical technique (one-versus two-stage surgery), tissue handling technique (reduction versus preservation), type of implant used, and complications. DATA SYNTHESIS: We selected 20 articles published between 2000 and 2017 for data extraction, encompassing 952 implanted BAHIs. The overall mean age at implantation was 8.6 years (range, 2-21 years). Adverse soft-tissue reactions occurred in 251 of the 952 implants (26.4%; range 0%-89% across studies). Revision surgery was performed in 16.8% (142 of the 845) of the implants. The total rate of implant loss, i.e. caused by OIF (n = 61), trauma (n = 33), recurrent infection (n = 15), elective removal due to insufficient benefit (n = 1), cosmetic reasons (n = 1), or unknown reason (n = 16), was 13.3% of the implants (127 out of 952; range 0%-40% across studies). Differences are seen in the type of implants used; wide-diameter implants seem to be superior in terms of implant survival, and similar in terms of adverse skin reactions, while one-stage surgery and soft-tissue preservation do not seem to result in higher implant loss rates or increased adverse skin reactions based upon limited amounts of literature. CONCLUSION: In general, BAHIs are a safe method for hearing rehabilitation in children, although large differences between studies are observed. The outcomes of new surgical techniques and implant designs in the pediatric population seem promising, but more research is needed before definitive conclusions can be drawn.

Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study.

BACKGROUND: For almost 30 years, bone-anchored prostheses have offered an alternative solution to prosthetic sockets by attaching the artificial limb directly to the femoral residuum by means of an osseointegration implant. Osseointegration implant surgery was introduced in our center in 2009. The aim of the present study is to report on safety, prosthesis-wearing time, and health-related quality-of-life (HRQoL) for patients with femoral bone-anchored prostheses during a 5-year follow-up period. METHODS: All patients who underwent implantation of a press-fit osseointegration implant between May 2009 and November 2013 were eligible for the present study. Implantation was performed in 2 stages. Adverse events included infectious complications (grade 1 to 4), aseptic loosening, breakage, stoma-redundant tissue, and stoma hypergranulation. Prosthesis-wearing time and HRQoL were measured with the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) prosthetic use score and global score, respectively. RESULTS: Thirty-nine of 42 eligible patients were included. Thirty patients (77%) presented with some kind of infection (156 events in total), with 148 (95%) events being classified as grade 1 or 2 and 8 events (5%) being classified as grade 3; the latter 8 events occurred in 4 patients. There were no instances of septic loosening. The intramedullary stem of the osseointegration implant broke in 2 patients. In total, soft-tissue refashioning had to be done 30 times in 14 patients. The Q-TFA median prosthetic use and global scores improved significantly from 71 to 100 and from 33 to 75, respectively (p < 0.001). CONCLUSIONS: Despite the adverse events, patient prosthetic use and HRQoL improved significantly. Grade-1 and 2 infections were frequent but could mostly be treated with nonoperative measures. Most infections seemed to occur in the first 2 years and did not lead to deep infections. Two broken intramedullary stems were revised successfully. Current developments focus on reduction of infectious complications and prevention of osseointegration implant breakage. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Outcomes of BAHA connect vs BAHA attract in pediatric patients.

INTRODUCTION: Two of the most commonly employed bone-anchored hearing implant (BAHI) systems are the BAHA Connect and BAHA Attract. The BAHA Connect uses a skin-penetrating titanium abutment. The BAHA Attract uses an implanted magnet, leaving the overlying skin intact. Limited data is available on the difference in complication rates between the two systems. Our hypothesis was that there would be no difference in complications and audiologic data. METHODS: Retrospective chart review was performed of patients who had BAHA Connect vs. Attract at our tertiary care pediatric hospital from 2006 to 2018. Pre- and post-operative information, including demographics, related diagnoses, outcomes and complications were compared between the systems using Mann-Whitney U tests and Firth logistic regression for one year post-implant. Audiology data was analyzed with Wilcoxon rank-sum and Wilcoxon matched pairs signed rank tests. RESULTS: Twenty-four Attract and 18 Connect BAHA surgeries were identified from 37 patients. Eleven Connect patients had the surgery completed in two stages. Connect patients followed up an average of 6.5 years post-implant and 15 months for Attract. A total of 58.8% of patients with Connect surgeries had complications within a year and 82.4% had a complication by their last follow-up. Aside from magnet strength related issues, there were no major complications with Attract surgery at any time point. Patients with Connect surgeries had significantly more skin overgrowths, cultured infections, times on antibiotics, nursing phone calls, and ENT visits within the first year and for all records, p < .05. The pure-tone average was significantly lower for both Connect [unaided-M(SD) = 61.7(9.8); aided-M(SD) = 26.4(5.5) and Attract (unaided-M(SD) = 66.0(22.5); aided-M(SD) = 25.6(6.1)] after implant, p < .001. CONCLUSION: Implantation of both systems lead to improved hearing outcomes with profoundly different complication rates.

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study.

BACKGROUND: We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants. METHODS: All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up. RESULTS: Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening's occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25th to 75th PCTL) Q-TFA PUS and GS were 52±39, 52(7-90) and 40±19, 42(25-50) and improved significantly to 88±18, 90 (90-100) and 71±15, 75 (67-83) at one-year follow-up. The GS Q3 improved over time. CONCLUSION: Titanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.

Trochanteric femoral nonunion in patients aged over 60 years treated with dynamic condylar screw.

INTRODUCTION: Nonunions of trochanteric femoral fractures are uncommon due to a good blood supply of the cancellous bone of the trochanteric region. Nevertheless, if a nonunion occurs, complex revision procedures usually become necessary. The purpose of this study was to evaluate a series of aseptic trochanteric nonunions in patients aged 60 years or older, looking at outcomes regarding healing rate, implant-related complications and secondary surgeries. MATERIAL AND METHODS: We conducted a retrospective chart review of patients with aseptic femoral trochanteric nonunions aged over 60 years. Nonunion treatment consisted of implant removal, debridement of the nonunion, and restoration of the neck shaft angle, followed by DCS plating. An additional 4.5-mm limited contact dynamic compression plate was placed in twelve patients anteriorly. The primary outcome measure was bony healing and time to healing in months. Secondary outcome measures included postoperative complications related to the index procedure, range of motion of the affected hip and postoperative mobility. RESULTS: A total of 21 patients with a mean age of 69.1 years met the inclusion criteria. After a mean follow-up of 21.62 months, 17 of the 21 nonunions healed successfully. The mean healing time was 6.59 months. A total of six of the 21 patients needed secondary revision surgery. At the final follow-up, a full range of motion of the hip was seen in 17 of the 21 hips. CONCLUSIONS: DCS treatment and preservation of the patient's femoral head can be successful for patients aged over 60 years with a well-preserved femoral head and acetabulum. However, preservation of the hip joint and revision plating might be associated with higher revision rates.

Comparing Heterotopic Ossification in Two Cervical Disc Prostheses.

STUDY DESIGN: Retrospective analysis using data from randomized clinical trials. OBJECTIVE: To compare the occurrence of heterotopic ossification (HO) between two cervical disc prostheses. Clinical outcome and range of motion (ROM) were also evaluated. SUMMARY OF BACKGROUND DATA: Cervical arthroplasty was reported to be able to maintain the segmental ROM. However, controversy exists since the difference of the occurrence of HO concerning cervical prosthesis is still huge. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy due to a herniated disc from the The Netherlands Cervical Kinematics (NECK) trial (activC; metal endplates with a polyethylene inlay and a keel for primary stability) and the PROCON trial (Bryan; metal-on-polymer with titanium coated endplates without a keel) were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. Segmental ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the neck disability index (NDI) as well as physical-component summary (PCS) and mental-component summary (MCS). RESULTS: At 2-year follow-up, the occurrence of HO was 68% in patients treated with the activC prosthesis (severe HO 55%), which was comparable with 85% (P = 0.12) in patients with the Bryan disc (severe HO 44%; P = 0.43). The HO progression was similar between groups. Clinically, the patients had comparable NDI, PCS, and MCS at 2-year follow-up, and comparable improvement of clinical outcomes. The global ROM in the Bryan group (56.4 ±â€Š10.8°) was significantly higher than in the activC group (49.5 ±â€Š14.0, P = 0.044) at 2-year follow-up. CONCLUSION: In comparison of two cervical disc prostheses the development of HO is independent on their architecture. Although global ROM was higher in the Bryan prosthesis group, this difference was not deemed clinically important, particularly because the clinical condition of patients with and without severe HO was comparable. LEVEL OF EVIDENCE: 2.

Inter-rater Reliability and Validity of Holgers Scores for the Assessment of Bone-anchored Hearing Implant Images.

OBJECTIVES: This study aims to review the utility and interassessor reliability of Holgers classification by simultaneously testing various professionals of the bone-anchored implant team for their impression of a series of randomized images. STUDY DESIGN: Retrospective review of a randomized series of bone-anchored implant fixture clinical photographs from the database at a tertiary referral university hospital. Raters were blinded to the contemporaneous Holgers grading assigned by the Clinical Nurse Specialist at initial assessment. Multivariate analysis was performed for correlation between scores for assessors and between grades of assessor. SETTING: Queen Elizabeth Hospital, Birmingham, UK a tertiary center for BAHIs. PATIENTS: Patients implanted from May 2012 until November 2014. MAIN OUTCOME MEASURE: Photographs of fixture sites of adult patients were taken following bone-anchored hearing implant surgery using either a tissue reduction (a split skin graft or linear incision technique was used) or tissue preservation approach, at 1 week, 6 months, and 12 months postoperatively. On a single occasion 263 images were reviewed by 10 assessors (2 consultants, 2 higher surgical trainees, 3 junior doctors, and 3 audiologists). Images were displayed at 10-second intervals and were scored by each assessor. Assessors were blinded to patient identity, time points and to each other's scores. Results were then compared against the real-time scoring of Holgers grades done by the BAHI specialist nurse to compare scores. RESULTS: Overall 227 (86.2%) images were with tissue reduction technique of which 110 (41.8%) were with linear incision and 117 (44.4%) were with a split skin graft (SSG); and 36 (13.6%) were with tissue preservation technique. Of these 263 images, 104 were at 1 week (39.5%), 70 were at 6 months (26.6%), and 89 were at 12 months (33.9%). The cumulative scores for each grade scored by blinding the time points were: 0 = 1132 (43.04%), total 1 = 995 (37.83%), total 2 = 346 (13.15%), total 3 = 141 (5.36%), total 4 = 16 (0.6%). 2630 data points had a variance of only 0.6415 for each nominal. Multivariate correlation between all assessors was r =0.7230 (Pearson's R). Correlations between consultants r=0.6317, higher surgical trainees r=0.7351, junior doctors r=0.7599, and audiologists r=0.7981.There is a good correlation (r=0.89) with no statistically significant differences between the SSG and linear incision groups (p>0.05), possibly suggesting Holgers score is comparable within both these tissue reduction techniques.There is a moderate correlation (r=0.58) with statistically significant differences between tissue preservation versus tissue reduction groups (p<0.05), possibly suggesting tissue preservation gives better results with lower Holgers scores than tissue reduction. CONCLUSION: Holgers scoring system is a reliable tool with respect to inter-rater variability across all levels of experience. Correlation was closer with audiologists and lesser experienced assessors.

Implant-based factor as possible risk for peri-implantitis.

Peri-implantitis is currently a topic of major interest in implantology. Considered one of the main reasons of late implant failure, there is an emerged concern whether implant characteristics could trigger inflammatory lesion and loss of supporting bone. The purpose of this narrative review is to provide an evidence based overview on the influence of implant-based factors in the occurrence of peri-implantitis. A literature review was conducted addressing the following topics: implant surface topography; implant location; occlusal overload; time in function; prosthesis-associated factors (rehabilitation extension, excess of cement and implant-abutment connection); and metal particle release. Although existing data suggests that some implant-based factors may increase the risk of peri-implantitis, the evidence is still limited to consider them a true risk factor for peri-implantitis. In conclusion, further evidences are required to a better understanding of the influence of implant-based factors in the occurrence of peri-implantitis. Large population-based studies including concomitant analyses of implant- and patient-based factors are required to provide strong evidence of a possible association with peri-implantitis in a higher probability. The identification of these factors is essential for the establishment of strategies to prevent peri-implantitis.

New strategies and developments for peri-implant disease.

The aim of this illustrated review is to present the new strategies and developments to treatment and diagnosis of periimplant diseases. Periimplant disease is a subject of great concern for modern dentistry. The numbers of implant exhibiting biological complications grows as implant dentistry expands thought-out the world. Diagnosis and treatment of those diseases are still controversial and difficult. We present novel treatment for infection control and biological rationale of additional use of guided bone regeneration, with an illustrative explanation of the treatments presented with two cases.

Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications.

INTRODUCTION: Direct skeletal attachment of prostheses has previously been shown to improve patient-reported outcome (PRO) measures of individuals with transfemoral amputation (TFA) at 2-year follow-up. This prospective study reports the outcomes at 5-year follow-up. METHODS: A total of 51 patients (55 legs) with TFA were included in a prospective study. Complications, success rate, and PRO measures were followed for 5 years. RESULTS: The cumulative fixture survival rate at 5 years was 92%, and the revision-free survival rate was 45%. Thirty-four patients had 70 superficial infections. Eleven patients had 14 deep infections. Fifteen patients had mechanical complications. Four fixtures were removed (ie, one deep infection and three loosening). PRO measures showed significant improvements including more use of the prosthesis, better mobility, fewer issues, and improved physical health-related quality of life (all P < 0.0001) compared with baseline. CONCLUSION: Individuals with TFA at 5-year follow-up had significant improvement in PRO measures, but increases in deep infections and mechanical complications are concerning.

Treatment of peri-implant soft tissue defects: a narrative review.

Soft tissue defects around dental implants, such as papilla or volume loss, peri-implant recession and alterations of the ridge color and/or texture, lead to esthetic and functional complaints. Treatments of these defects in implants are more demanding than in teeth because peri-implant tissue exhibits different anatomical and histological characteristics. This narrative review discusses the proposed treatments for soft tissue defects around implants in the current literature. Several clinical and pre-clinical studies addressed methods to augment the quantity of the peri-implant keratinized mucosa. Autogenous grafts performed better than soft tissue substitutes in the treatment of soft tissue defects, but there is no clinical consensus on the more appropriate donor area for connective tissue grafts. Treatment for facial volume loss, alterations on the mucosa color or texture and shallow peri-implant recessions are more predictable than deep recessions and sites that present loss of papilla. Correction of peri-implant soft tissue defects may be challenging, especially in areas that exhibit larger defects and interproximal loss. Therefore, the regeneration of soft and hard tissues during implant treatment is important to prevent the occurrence of these alterations.