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Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant

Study acronym: OSTEO-OUTCOME
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Sep 2026 to Oct 2026v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Jan 31, 2025
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 the external prosthesis. Osteointegrated prostheses are widely accepted worldwide as a valid alternative to socket prostheses, especially for young and active individuals with transfemoral, transtibial, transhumeral, or transradial amputations not caused by vascular issues. The key benefit of osteointegration is the restoration of load alignment along the anatomical and mechanical axis, improving control of the residual limb during walking, as well as overall functional capacity and quality of life. Other advantages include greater stability, enhanced sitting comfort, a wider range of hip movement, faster attachment and detachment of the prosthesis, and improved body perception. Additionally, the direct contact between the metal stem and the bone generates sensory feedback (osteoperception), allowing the patient to better control the amputated limb by perceiving ground contact through vibrations transmitted to the bone. Osteointegration offers the only viable alternative for prosthetic use in patients with a short residual limb, where conventional socket prostheses would not be suitable.
Trial Details
NCT Number NCT06737770
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)
Prosthesis, Lower Limb Amputation Knee, Amputation; Traumatic, Leg, Lower
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov