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. 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.Aims
Methods
This study reports on minimum 2 year follow up outcomes on functional and quality of life of patients after undergoing bilateral osseointegration in comparison to traditional socket prosthesis. This is a prospective pilot study of 35 patients, consisting of 30 males and 5 females, aged 22–66 (mean 36) years at surgery, with minimum two-year follow-up. Selection criteria were age over 18 years, bilateral amputees who had socket-related problems or were wheelchair-bound with short stumps and non-reconstructable limb pathology. Principle 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), Timed Up and Go (TUG), and K-levels. Adverse events were recorded including infection, revision surgery, fractures, and implant failures.Introduction
Materials & Methods
Osseointegration has emerged as a promising alternative to rehabilitating with a traditional socket mounted prosthesis. Advantages have been reported to include improved functional mobility, better osseoperception, improved comfort, reduced pain, better biomechanical alignment and better gait, which all lead to a less restricted lifestyle and significantly improved quality of life. A major concern of the Osseointegrated approach lies in the risk of infections occurring from the permanent transcutaneous opening often referred to as the stoma. Several systematic reviews have indicated that the occurrence of minor infections can be quite common, serious complications are reported to be rare. In addition to commonly anticipated complications including fractures, surgical debridements or revisions, we have identified several significant events in which a patient may require to be readmitted and go through additional surgery. The objective of this study is to examine the rate of occurrence and reports on the best management practices of serious complications across a multi-centre review of more than 1000 osseointegration surgeries. A detailed analysis has been performed on all osseointegration surgeries performed by the Osseointegration Group of Australia and it's affiliates between since 2010. The majority of surgeries took place in Australia, the United States, the Middle East as well as in Europe. All events leading to a re-admission and subsequent re-operation have been identified through hospital operation records and pooled together for meta-analysis. Events identified include: revision of implants, periprosthetic fracture fixation, surgical debridement due to infections, neurectomies and soft- tissue refashioning.Introduction
Materials & Methods
Traditional socket prosthesis (TSP) rehabilitation for amputees is associated with substantial dissatisfaction due to poor mobility and pain from soft tissue squeezing. Osseointegration (OI), eliminates skin compression and prosthesis fit issues, providing superior mobility and quality of life (QOL) for most amputees. The potential for OI to benefit patients with exceptionally poor mobility is understudied. To address this knowledge gap, this project investigated the mobility and QOL changes. A retrospective review was performed to identify transfemoral amputees who presented with wheelchair-bound mobility (K0) and had at least five years of post-osseointegration follow-up. Outcome measures included changes in mobility (K-level, daily prosthesis wear hours, Timed Up and Go (TUG), 6 minute walk test (6MWT)) and QOL (Questionnaire for persons with a Transfemoral Amputation (QTFA); Short Form Health Survey 36 (SF36). Adverse events recorded included debridement for infection, implant revision surgery, fractures, and implant failures. 9 patients with mean age 48.2±7.7 (range 34-59) years were included. The proportion of patients achieving K-level >2 improved from 0/9=0% to [9/9=100%], p<0.001. The 6MWT improved from 0±0 to 320.65±57 meters (p<0.001). The TUG improved from incapable to 10.68±2.7 seconds (p<0.001). Statistically significant QOL metrics included QTFA global score (33.33±31 vs 68.52±21, p=0.039), SF36 physical component score (30.03±6.3 vs 42.34±12, p=0.023) and the SF36 mental component score (47.89±8.8 vs 51.95±10.4, p=0.332). Six patients required operative intervention to address complications. Five developed infections: three had debridement, and 2 required implant removal and reimplantation. Osseointegration does confer significant sustained mobility and quality of life improvement for wheelchair bound transfemoral amputees. All 9 K0 patients had statistically improved mobility and QOL after osseointegrated reconstruction. This supports osseointegration as an effective rapid and long-term rehabilitation alternative for patients who have the neurologic and muscular capacity to walk but are unable due to issues related to their TSP.
Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputee's discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14-16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL. Retrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma. The residual femurs on average started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery. At a mean of 3.4±0.6 (2.6-4.4) years following osseointegration six patients had K-level >2. The 6 Minute Walk Test remained unchanged (267±56 vs 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection. Extremely short residual femurs which make TSP use troublesome can be lengthening with externally controlled telescoping nails, and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regenerate or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee's expectations before beginning on a potentially arduous process.
Osseointegration is a potential treatment option for transfemoral amputees experiencing socket related problems. Till this date, there is little data assessing the feasibility and advantages of osseointegration in individuals with transtibial amputations. We prospectively followed 91 patients undergoing transtibial osseointegration from 2014–2018 who either 1) reported pain or mobility dissatisfaction with socket prosthesis; 2) had an intact limb with incapacitating pain, complex deformity, or profound distal weakness or 3) were recent amputees preferring osseointegration. Adverse events were monitored including infection, periprosthetic fracture, implant breakage, aseptic loosening, revision surgery/additional amputation and death. Functional outcomes were measured using the Questionnaire of persons with a Trans-femoral amputation (Q-TFA) and mobility was assessed using Six Minute Walk Test (6MWT) and Time Up and Go (TUG).Introduction
Materials and Methods
Osseointegration has been established as a promising approach for the reconstruction of amputated limbs, particularly for amputees suffering from traditional socket prosthesis (TSP). While Osseointegration was originally developed with a screw fixation design, several Osseointegration devices adopting a modern press-fit design have also been introduced. In this study, medium-term outcomes for patients with the two most common press-fit osseointegration implant used worldwide are analysed. This is a cross-sectional analysis containing a cohort of Osseointegration patients treated in several centres worldwide. We analyzed a total of 93 patients with an average follow-up time of 6.52 years. Functional, Mobility and patient reported outcomes were collected pre-operatively and during follow-up. All postoperative adverse events (infection, revision surgery, fractures, and implant failures) were also analyzed.Introduction
Materials and Methods
Advantages of osseointegration have been reported to include improved functional mobility, better osseoperception, improved comfort, reduced pain, better biomechanical alignment and gait, which all lead to a less restricted lifestyle and significantly improved quality of life. A major concern of the Osseointegrated approach lies in the risk of infections occurring from the permanent transcutaneous opening often referred to as the stoma. Detailed analysis has been performed on all osseointegration surgeries performed by the Osseointegration Group of Australia and it's affiliates since 2010. All events leading to a re-admission and subsequent re-operation have been identified through hospital operation records and pooled together for meta-analysis. Events identified include: revision of implants, periprosthetic fracture fixation, surgical debridement due to infections, neurectomies and soft- tissue refashioning.Introduction
Materials and Methods
OA knee with subchondral cyst formation presented differential microstructure and mechanical competence of trabecular bone. This finding sheds light on the pivot role of subchondral cyst in OA bone pathophysiology. Subchondral bone cyst (SBC) is a major radiological finding in knee osteoarthritis (OA), together with joint space narrowing, osteophyte and sclerotic bone formation. There is mounting evidence showing that SBC originates in the same region as bone marrow lesions (BMLs). The presence of subchondral bone cyst (SBCs), in conjunction with BMLs, was associated with the severity of pain, and was able to predict tibial cartilage lolume loss and risk of joint replacement surgery in knee OA patient. It is speculated that the presence of SBCs might increase intraosseous pressure of subchondral bone, and trigger active remodeling and high turnover of surrounding trabecular bone. Yet the exact effect of SBC on the structural and mechanical properties trabecular bone, which provides the support to overlying articular cartilage, remains to be elucidated. Therefore, this study aimed to investiate the microstructure and mechanical competence of trabecular bone of knee OA in presence or absence of SBC.Summary Statement
Introduction