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Bone & Joint Open
Vol. 4, Issue 7 | Pages 539 - 550
21 Jul 2023
Banducci E Al Muderis M Lu W Bested SR

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.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 13 - 13
1 Jun 2023
Lu W Oomatia A Al Muderis M
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Introduction. 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. Materials & Methods. 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. Results. Comparisons were made using differences between the mean pre-operative and mean post-operative values for each outcome measure. Significant improvements in all validated outcome measures were observed. All patient who were wheelchair bound prior to the surgery were able to mobilise post operatively. The occurrence levels of adverse events, including the infection rate and revision rate within this patient cohort, were similar to other established trans-femoral osseointegration studies. Conclusions. These preliminary results indicate that osseointegration surgery is a safe and effective alternative treatment for bilateral amputees experiencing socket-related discomfort. Compared to the suboptimal outcomes of socket prostheses, osseointegration currently provides one of the best chances for any bilateral amputee to walk again and regain the ability to perform daily activities


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 14 - 14
1 Jun 2023
Ong G Hoellwarth J Oomatia A Al Muderis M
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Introduction. Approximately 2,000 Skeletal transcutaneous osseointegration (STOI) procedures have been performed worldwide as of 2020, more than half of which have been performed by the Osseointegration Group of Australia using a press-fit technique with either ILP or OPL implant designs. Despite the consistently demonstrated clinical benefits, concerns regarding potential complications following STOI have slowed its widespread adoption. As more patients are followed for a longer period of time, longitudinal studies have confirmed complication rates are very acceptable, similar to those of total ankle and total elbow replacements. One of the major risk category is implant removal. The primary goal of this study was to investigate the complications and technical issues associated with transtibial osseointegration implant removal due to any cause. The focus here will be on the press-fit ILP and OPL implants, including the indications for removal and patient outcomes following removal. Materials & Methods. A review of our osseointegration registry between November 2010 and March 2022 was performed. Inclusion criteria were patients who have undergone removal of a transtibial osseointegration implant due to any cause. Selected patients either had a follow-up of at least two years or had their index osseointegration surgery at least two years prior to when the study was performed. Patients who have had osseointegration at other anatomic levels, and patients who underwent simultaneous total knee replacement with transtibial osseointegration were excluded from the registry search. Results. There were a total of 148 transtibial osseointegration procedures performed during the study period, with 97 (65.5%) performed in males and 51 (34.5%) performed in females. The average age at first stage osseointegration procedure is 50.4 years (range 16.8–87.9, SD 14.1). In the study cohort of 22 cases requiring implant removals, 12 (54.5%) were male and 10 (45.5%) were female. The average age at first stage osseointegration procedure in this cohort is 51.3 (range 37.4–82.6, SD 10.7) and average BMI 30.3 (range 21.9–40.9, SD 5.8). Although men comprised the majority of removals, women had a greater relative risk (Fisher exact test p=0.032). The average duration from time of STOI to removal was 2.6 years (range 0.1–6.8, SD 1.9) within this 11.5 year follow-up period. The most frequent indication was infection (54.6%, n=12) followed equally by pain (13.6%, n=3), aseptic loosening (13.6%, n=3) and implant fracture (13.6%, n=3), and lastly failure to integrate (4.6%, n=1). Conclusions. Of the 22 removals, 12 were reimplanted at the same anatomical level (10 were reimplanted within 6 months, 1 within 12 months, and 1 within 24 months). 11 of these cases currently wear their prosthetic legs for more than 13 hours daily. 1 case was recently reimplanted and still completing their loading program. Of the patients who were not reimplanted at the same anatomical level, 1 required proximal amputation with transfemoral osseointegration. 3 patients converted to traditional socket prostheses (TSP) due to pain, and 1 underwent proximal amputation and converted to TSP due to infection. 3 cases are currently awaiting transtibial osseointegration reimplantation, and 1 patient was deceased. 1 patient was lost to follow-up


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 205 - 205
1 Dec 2013
Widmer K
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Introduction:. Dislocation is still one of the major complications in total hip arthroplasty. Among other factors, it is important to maximize the intended range of movement (iROM) in order to reduce the risk for prosthetic impingement and to prevent edge loading in order to avoid surface damage and squeaking. Therefore, both components should be positioned in accordance to the new combined safe-zone for correct combined version and inclination aiming for an optimal relative orientation of both components. This study shows how this optimal combined orientation of both components can be determined for a specific total hip prosthetic system and how the result can be transferred to surgery and accomplished intraoperatively using minimal-invasive stem-first technique. Material and Methods:. 829 minimal-invasive total hip arthroplasties have been performed from 2007 to 2013 in our institution. In all of these surgeries a minimal-invasive direct anterior approach (DAA) was applied. All patients were positioned supine on a proprietary orthopedic table. In 168 cases a system-specific mechanical aiming device was used intraoperatively in order to control the combined version and inclination according to the specific safe-zone by orienting the prosthetic socket in relation to the prosthetic stem. This is called “stem-first technique” meaning that the prosthetic stem dictates the orientation of the socket. It does not mean the sequence of implantation. It's specific advantage is that the stem redirects the socket if it's position is modified. It equally applies to standard, anatomic (Fig. 1) or short stems (Fig. 2). The socket orientation is not primarily referred to bony landmarks of the pelvis but to the neck of the stem. Nevertheless the surgeon has to look for sufficient fixation of the socket within the acetabular bone. Leg length was measured in the surgical field additionally and prosthetic offset was adjusted according to the preoperative planning. All other patients were operated on in our standard minimal-invasive DAA-procedure. The majority of the patients suffered from osteoarthritis, their mean age was 68 years. Results:. Optimal component orientation for each prosthesis system was derived from its 3D-model by simulating hip joint motion in the physiologic range of motion. Optimal component orientation means maximizing the area of the combined safe-zone. In the stem-first group cup orientation was in the new combined safe-zone in 94% of the cases and no squeaking or prosthetic impingement did occur in any of these patients. Leg length did not differ more than +/− 5 mm. 83% of all patients receiveda ceramic-on-ceramic articulation, one early dislocation did occur and treated by closed reduction. Conclusion:. Stem-first technique is ideally suited for the minimal-invasive direct anterior approach in total hip arthroplasty to control the combined orientation of the prosthetic components and to achieve excellent clinical results. It assists the surgeon in aligning the cup and the stem according to their correct combined orientation in order to get an optimal range of movement especially in young patients