Leijendekkers R.A.1, van Hinte G.1, Staal J.B.2,3, Frölke J.P.4, van de Meent H.5, Nijhuis-van der Sanden M.W.G.1,2,5, Hoogeboom T.J.2
1Radboud University Medical Center, Department of Orthopaedics, Physical Therapy, Nijmegen, Netherlands, 2Radboud University Medical Center, Scientific Center for Quality of Care, Nijmegen, Netherlands, 3HAN University of Applied Sciences, Research Group Musculoskeletal Rehabilitation, Nijmegen, Netherlands, 4Radboud University Medical Center, Department of Surgery, Nijmegen, Netherlands, 5Radboud University Medical Center, Department of Rehabilitation, Nijmegen, Netherlands
Background: Patients with lower extremity amputation frequently suffer from socket-related problems seriously limiting prosthesis use leading to limitations in the level of activity and health-related quality of life (HRQoL). Bone-anchored prostheses (BAPs) are a possible solution for socket-related problems. Knowledge concerning the level of function, activity and HRQoL after surgery is limited. No research has been done concerning the patients' level of satisfaction in regards to their prosthesis. This is remarkable, because BAP surgery is an invasive intervention aimed to overcome socket-related problems and associated problems in physical functioning.
Purpose: To describe the change in the level of function, activity, HRQoL and satisfaction in patients with a lower extremity amputation after receiving a press-fit BAP at six-months and one-year follow-up in comparison to baseline.
Methods: This is a prospective before-after study with follow-ups at six- and twelve-months after surgery and one baseline assessment. Adults with a lower extremity amputation suffering from socket-related problems who received a press-fit BAP between May 2014 and July 2015 were included. The outcome measures were: a) function-level defined as hip abductor strength (handheld dynamometer) and prosthetic use (Questionnaire for Persons with Transfemoral Amputation (Q-TFA) prosthetic use score); b) activity-level defined as mobility level (Timed Up and Go (TUG)) and walking ability (6-Minute Walking Test (6MWT) and patient-reported estimation of the walking distance in daily life); c) HRQoL-level (Q-TFA global score); d) satisfaction-level regarding prosthesis comfort (Prosthetic Comfort Score (PCS)). Changes over time were analyzed using generalized estimating equations (GEE).
Results: All 28 potentially eligible patients (17 men) were included in the study (median age: 56 year, range: 28-70 year). In these patients 29 BAPs were implanted of which 25 on a transfemoral (one bilateral) and 4 on a transtibial level. The six- and twelve-months follow-up visits were completed for 27 and 28 patients, respectively. At baseline 25% and at follow-ups 0% of the patients were wheelchair-bounded. Relative to baseline, hip abductor strength in both limbs increased significantly (six-months: 0.13-0.15Nm (p 0.05); twelve-months: 0.19Nm (p 0.001)) and prosthesis wearing time increased significantly (six-months: 33points (p 0.001); twelve-months: 36points (p 0.001)). The TUG scores improved significantly at the twelve-months follow-up (six-months: -0.7s; twelve-months: -2.0s (p 0.05)), the 6MWT scores did not change significantly and the patient-reported walking distance increased significantly (six-months: 1217m (p 0.05); twelve-months: 2073m (p 0.05)) relative to baseline. HRQoL-level increased significantly (six-months: 24points (p 0.001); twelve-months: 22points (p 0.001)) and the PCS increased significantly (six-months: 2.7points (p 0.001); twelve-months: 3.0points (p 0.001)) relative to baseline.
Conclusion(s): The influence of BAP surgery in combination with rehabilitation was in particular positive on function-, HRQoL- and satisfaction-level in patients with socket-related problems, both for patients with a transtibial as transfemoral amputation. The outcomes on activity level were inconclusive. Patient-reported outcomes changed positively, in particular, and to a lesser extent, the results of objective tests.
Implications: One obvious health benefit of the described intervention, which has a large impact on patients lives, is reduction of wheelchair-boundedness to 0% at both follow-ups.
Funding acknowledgements: No funding to declare.
Topic: Disability & rehabilitation
Ethics approval: The protocol of this study (registration number 2014/196) was approved by the Ethics Committees of Radboud university medical centre.
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