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The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study

      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)
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