Original articleOutcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up
Section snippets
Methods
The OPRA treatment involves 2 surgeries 6 months apart, followed by a careful increase in implant loading and prosthetic activity over at least 6 months, resulting in a treatment period of about 1 year.7, 18 The OPRA study is composed of 51 patients treated with 55 implants (n=45 unilateral TFA, n=6 bilateral TFA of whom 4 were treated bilaterally) enrolled in the study from 1999 through 2007. Specific demographics have previously been described.18 The OPRA study protocol comprises assessments
Results
The results showed that 6 of 45 subjects with a unilateral TFA were not followed for 2 years for varying reasons (implant removed because of complications: n=3, deceased: n=1, lost to follow-up: n=1, withdrawn because of problems with contralateral limb: n=1).18 As a result, the data reported in this study are based on 39 subjects (17 men, 22 women) with unilateral TFA. The amputation was the result of trauma (n=23), tumor (n=11), or other cause (n=5). The mean age at amputation was 31±14.8
Discussion
This prospective study focused on individuals with a unilateral TFA treated with osseointegration and followed for 2 years. The results confirm earlier publications reporting that patients treated with the OPRA show important improvements with regard to prosthetic mobility and HRQOL.13, 14 In the evaluation of whether or not a bone-anchored prosthesis is an adequate treatment alternative, the patient should be given detailed realistic information, including possible benefits and complications.
Conclusions
This prospective study showed increased and large-scale daily prosthesis use, reduced problems, improved mobility, including more walking and decreased energy cost, and improved physical HRQOL in individuals with a unilateral TFA treated with the OPRA implants and followed over 2 years. However, there was no significant change in use of walking aids, trouble reported with regard to phantom limb pain, and pain problems from the back, shoulders, and contralateral limb compared with baseline.
Suppliers
- a.
Integrum AB, Krokslätts Fabriker 50, 43137 Mölndal, Sweden.
- b.
IBM Corp, 1 New Orchard Rd, Armonk, NY 10504-1722.
Acknowledgment
We thank Eva Häggström, CPO, Department for Prosthetics and Orthotics, Sahlgrenska University Hospital, for collection of data regarding prosthetic components.
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Cited by (91)
Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications
2023, Journal of Orthopaedic TranslationCitation Excerpt :Since 1999, the so-called OPRA study has followed 51 patients treated with 55 implants and reported prospective short-term (two years) [6] and mid-term (five years) [7] results. Other studies have reported on the benefits [8–11] and complications [10,12,13] following OPRA treatment. Considered together, the findings have shown large and important improvements in everyday life, mobility and HRQoL, accompanied by Adverse events (AEs) in terms of infection and other implant complications.
The effect of cortical thickness and thread profile dimensions on stress and strain in bone-anchored implants for amputation prostheses
2022, Journal of the Mechanical Behavior of Biomedical MaterialsLow plasticity burnishing improves fretting fatigue resistance in bone-anchored implants for amputation prostheses
2022, Medical Engineering and PhysicsCitation Excerpt :In 1999, this implant system was CE marked and standardized along with its surgical technique and rehabilitation protocol for transfemoral amputations. Since then, prospective clinical trials have shown that treatment with the OPRA Implant System leads to increased quality of life, increased prosthetic usage, improved mobility and reduced prosthesis related problems compared with conventional socket prostheses [10–12]. Similar findings have been reported with other implants for skeletal attachment of limb prostheses [13–15].
Supported in part by an ALF grant from Sahlgrenska University Hospital (grant no. ALF-GBG-138721), Promobila Foundation, Jimmy Dahlsten Fund, and Johan Jansson Foundation, all from Sweden.
Disclosures: Brånemark is a shareholder in the Integrum Company. No benefits in any form have been received directly or indirectly to the subject of this article. The other authors have nothing to disclose.