Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study

Abstract

Objectives:(1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.Design:Prospective cohort study.Setting:University medical centre.Subjects:A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016.Intervention:Osseointegration implant surgery followed by a predefined rehabilitation programme.Main measures:Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events.Results:Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline (P ⩽ 0.002). The TUG showed no change at 6-month follow-up (P = 0.420) but improved significantly at 12-month follow-up compared to baseline (P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT (P ⩾ 0.038) and back pain (P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users.Conclusion:Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

“…[20] One year follow-up results of a subcohort were published earlier. [5] The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement was followed for the preparation of the manuscript to ensure methodological quality provided in S1 Appendix. [21] The study was conducted according to the principles of the Declaration of Helsinki (64 th version, 19-10-2013).…”

“…Rehabilitation started one week after the second OI surgery, or 3 weeks after single stage OI surgery, with loading the full-length prosthesis based on pain (numeric grading score 0-10: aim score <5) building up to full bodyweight. [5,22]The rehabilitation was given in group sessions twice per week with sessions of two hours each and a total duration of 4 weeks or 11 weeks for tibial and femoral BAP, respectively. Follow-up visits including radiologic examination and performance tests were scheduled prior to stage 1 surgery and one year after stage 2 surgery.…”

“…[2] This results in a more physiological and stable prosthetic control, osseoperception, improved walking, and sitting conditions as well as eliminating the socket-residuum interface with all its associated problems. [3][4][5][6] Currently, there are two different OI systems commercially available. [7] The oldest, with the longest follow up evaluations, is the titanium screw fixation system developed by the Swedish Brånemark group and available as Osseointegrated Protheses for the Rehabilitation of Amputees Implant system (OPRA) manufactured by Integrum AB Sweden.…”

“…[15] Several studies have shown favourable performance data when comparing BAP to SSP leading to increased level of function, activity, and healthrelated quality of life. [1,[4][5][6]16] Previous risk-benefit studies of BAP using a press-fit OI have predominantly included selected individuals with transfemoral amputation treated with the curved press-fit osseointegration femur implant (OFI-C), both with a chromium-cobalt-molybdenum and a titanium alloy. [15] Currently almost half of the candidates referred to our center for OI treatment have either short femoral remnants or a transtibial amputation.…”

“…There are only a few case series with short follow up that report on safety and performance data of individuals with transtibial amputation. [5,[17][18][19] For further expansion of the application of BAP using OI in the broader population of individuals with a lower extremity amputation, insight in the risk/benefit ratio of the OFI-Y and OTI is needed; especially when compared to the risk/benefit ratio of the more widely used OFI-C.…”