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Study identifier: NCT06737770 Synced from ClinicalTrials.gov · July 28, 2026
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Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant

Condition: Prosthesis · Lower Limb Amputation Knee · Amputation; Traumatic, Leg, Lower  ·  Sponsor: Istituto Ortopedico Rizzoli

PhaseNA
Planned participants15
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

Limb amputation is a traumatic event that significantly reduces the ability to perform daily activities, impairs mobility, and lowers quality of life. In Italy, approximately 4 million people live with disabilities, with 1.2 million having motor disabilities. Among lower limb amputees (around 200,000), most are elderly, with amputations due to diabetic or vascular issues. Other groups include middle-aged adults (often victims of workplace accidents) and young individuals (victims of traffic accidents). Post-amputation rehabilitation mainly involves the use of prostheses, which, however, can cause skin problems due to the socket (the part that anchors the prosthesis to the residual limb). Among patients using a socket, 34-63% develop chronic skin issues and pain. Complications include excessive sweating, sores, abscesses, and irritation. Additionally, daily volume changes in the residual limb and long-term weight fluctuations further complicate the use of conventional prostheses. In the last two decades, research groups, assisted by experienced surgeons, have worked to develop implant solutions that bypass the socket and address these issues. One such solution is osteointegrated prostheses, which use the principle of osteointegration to anchor the prosthesis directly to the bone of the residual limb. A metal stem is surgically inserted into the medullary canal of the residual limb and fixed through bone growth, establishing a direct connection between the amputated limb and …

This description comes directly from the study's public registry record.

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Locations (1)

IRCCS Rizzoli Orthopedic InstituteBologna, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06737770