| Titre : | 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 (2022) |
| Auteurs : | Sarina Sinclair ; Peter J. Beck ; Joseph Webster ; Jayant Agarwal ; Bart Gillespie ; Phil Stevens ; Jeremy Gililland ; Erik Kubiak |
| Type de document : | Article |
| Dans : | Archives of Physical Medicine and Rehabilitation (Vol. 103, n° 11, 2022) |
| Article en page(s) : | p. 2092-2104 |
| Note générale : | https://doi.org/10.1016/j.apmr.2022.06.008 |
| Langues: | Anglais |
| Descripteurs : |
HE Vinci Amputés ; Os et tissu osseux ; Prothèse à ancrage osseux ; Réadaptation |
| Résumé : |
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 the lumbar spine and adjacent to distal porous coating with no radiographic evidence of resorption. compared socket system use pop significantly reduced prosthetic don doff times patient-reported problem scores. significant improvements mean mobility global health 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. |
| Disponible en ligne : | Oui |
| En ligne : | https://login.ezproxy.vinci.be/login?url=https://www.sciencedirect.com/science/article/pii/S0003999322005147 |
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