Abstract
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.
Keywords
List of abbreviations:
6MWT (six-minute walk test), AE (adverse event), BAP (bone-anchored prosthesis), BMD (bone mineral density), EFS (early feasibility study), FDA (Food and Drug Administration), IDE (Investigational Device Exemption), MCID (minimal clinically important difference), POP (percutaneous osseointegrated prosthesis), Ti (titanium), U.S. (United States)To read this article in full you will need to make a payment
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Article Info
Publication History
Published online: July 28, 2022
Accepted:
June 13,
2022
Received in revised form:
May 20,
2022
Received:
October 13,
2021
Footnotes
Funding was provided by the US Department of Veterans Affairs Rehabilitation Research and Development (RR&D) Service (Grant # 10I1RX0012808-01).
Clinical Trial Registration No.: ClinicalTrials.gov Identifier: NCT02720159.
Disclosures: This study describes a device limited to investigational use. J.P. Beck, J. Gililland, J. Agarwal, and E. Kubiak provided surgeon consultation services to the device manufacturer during the implant design and study periods. All conflicts of interest were reported and managed by the University of Utah Conflict of Interest committee.
Identification
Copyright
Published by Elsevier Inc. on behalf of the American Congress of Rehabilitation Medicine.
