Condition: Lower Extremity Amputation · Sponsor: Istituto Auxologico Italiano
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years. It is defined as a procedure in which a metal implant is directly anchored to the residual bone, attached to a prosthetic limb using a transcutaneous connector. The advantages of osseointegrated prostheses over conventional socket prostheses include stable fixation, significant increases in walking ability, range of motion and control of the prosthesis, and health-related quality of life. Moreover, bodyweight distribution results more similar to physiological conditions. No formal consensus exists for osseointegration surgery. However, based on the positive clinical experience, surgeons currently indicate this surgery for those patients who show poor tolerance of socket prostheses. The present study investigates neuro-physiologic and mechanical parameters of walking and balance in patients with lower limb amputation and osseointegrated prostheses and in matched patients with traditional socket prostheses to highlight strengths and weaknesses of the alternative technique with respect to the present standard of care. The primary endpoint is the investigation of the neurologic and mechanic adaptation in terms of a) kinematic and dynamic segmental analysis of walking and transfer of the body center of mass during walking; b) capacity to retain balance in…
This description comes directly from the study's public registry record.
Luigi Tesio, MD, Professor · +39 02 58218151 · l.tesio@auxologico.it
Stefano Scarano, MD, Research Fellow · +39 02 58218717 · s.scarano@auxologico.it
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| Istituto Auxologico Italiano | Milan, MI, Italy | Recruiting |
| ASST Gaetano Pini-CTO | Milan, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04934839