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