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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.


The Bone & Joint Journal
Vol. 100-B, Issue 4 | Pages 527 - 534
1 Apr 2018
Hansson E Hagberg K Cawson M Brodtkorb TH

Aims

The aim of this study was to compare the cost-effectiveness of treatment with an osseointegrated percutaneous (OI-) prosthesis and a socket-suspended (S-) prosthesis for patients with a transfemoral amputation.

Patients and Methods

A Markov model was developed to estimate the medical costs and changes in quality-adjusted life-years (QALYs) attributable to treatment of unilateral transfemoral amputation over a projected period of 20 years from a healthcare perspective. Data were collected alongside a prospective clinical study of 51 patients followed for two years.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 218 - 226
15 Mar 2024
Voigt JD Potter BK Souza J Forsberg J Melton D Hsu JR Wilke B

Aims. Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Methods. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated. Results. For treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467. Conclusion. The use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness. Cite this article: Bone Jt Open 2024;5(3):218–226


Bone & Joint 360
Vol. 9, Issue 3 | Pages 31 - 34
1 Jun 2020


The Bone & Joint Journal
Vol. 102-B, Issue 2 | Pages 162 - 169
1 Feb 2020
Hoellwarth JS Tetsworth K Kendrew J Kang NV van Waes O Al-Maawi Q Roberts C Al Muderis M

Aims

Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees.

Methods

A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed.


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 221 - 226
1 Feb 2019
Ryan SP DiLallo M Klement MR Luzzi AJ Chen AF Seyler TM

Aims

The aim of this study was to characterize the factors leading to transfemoral amputation after total knee arthroplasty (TKA), as well as the rates of mortality and functional independence after this procedure in these patients.

Patients and Methods

This was a multicentre retrospective review with a prospective telephone survey for the assessment of function. All patients with a TKA who subsequently required transfemoral amputation between January 2001 and December 2015 were included. Demographic information, medical comorbidities, and postoperative mortality data were collected. A 19-item survey was used for the assessment of function in surviving patients.


The Bone & Joint Journal
Vol. 96-B, Issue 1 | Pages 106 - 113
1 Jan 2014
Brånemark R Berlin Ö Hagberg K Bergh P Gunterberg B Rydevik B

Patients with transfemoral amputation (TFA) often experience problems related to the use of socket-suspended prostheses. The clinical development of osseointegrated percutaneous prostheses for patients with a TFA started in 1990, based on the long-term successful results of osseointegrated dental implants.

Between1999 and 2007, 51 patients with 55 TFAs were consecutively enrolled in a prospective, single-centre non-randomised study and followed for two years. The indication for amputation was trauma in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical procedure was used to introduce a percutaneous implant to which an external amputation prosthesis was attached. The assessment of outcome included the use of two self-report questionnaires, the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short-Form (SF)-36.

The cumulative survival at two years’ follow-up was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p < 0.001). The physical function SF-36 scores were also improved (p < 0.001). Superficial infection was the most frequent complication, occurring 41 times in 28 patients (rate of infection 54.9%). Most were treated effectively with oral antibiotics. The implant was removed in four patients because of loosening (three aseptic, one infection).

Osseointegrated percutaneous implants constitute a novel form of treatment for patients with TFA. The high cumulative survival rate at two years (92%) combined with enhanced prosthetic use and mobility, fewer problems and improved quality of life, supports the ‘revolutionary change’ that patients with TFA have reported following treatment with osseointegrated percutaneous prostheses.

Cite this article: Bone Joint J 2014;96-B:106–13.