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

Published:July 28, 2022DOI:https://doi.org/10.1016/j.apmr.2022.06.008
The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective One-year Follow-up Cohort Study
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      Abstract

      Objective

      Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study.

      Design

      Single center, prospective one-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.

      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, 32-68y) with mean time since amputation of 9.4 ± 5.6 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 following 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, 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

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      Article Info

      Publication History

      Accepted: June 13, 2022
      Received in revised form: May 20, 2022
      Received: October 13, 2021

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Acknowledgements: Dr. Ami Stuart, Ph.D., Jacob Smith M.A., Dr. Sarah Turley, Ph.D., and Dr. Toni Roberts, M.D. are acknowledged for their contributions to this research study. Funding was provided by the US Department of Veterans Affairs Rehabilitation Research and Development (RR&D) Service (Grant # 10I1RX0012808-01). The funding agency had no role in study design, analysis, or manuscript preparation.

      Conflicts: JP 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.

      ClinicalTrials.gov Identifier: NCT02720159

      Disclosure: This study describes a device limited to investigational use.

      Identification

      DOI: https://doi.org/10.1016/j.apmr.2022.06.008

      Copyright

      © 2022 Published by Elsevier Inc. on behalf of the American Congress of Rehabilitation Medicine

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