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

RecruitingNAAges 18 Years - 65 YearsAllIstituto Ortopedico Rizzoli
NCT06737770 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects of both sexes, aged between 18 and 65 years; * Subjects with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect; * Subjects already scheduled for osteointegrated prosthesis surgery for amputation; * BMI \< 35 kg/m²; * Difficulty in using the traditional socket prosthesis (pain, reduced mobility, short residual limb, skin infections, ulcers, volume changes in the residual limb); * Subjects who have signed informed consent and reviewed the study information sheet. Absolute exclusion criteria: * Peripheral vascular diseases; * Pregnancy; * Rheumatoid arthritis; * Neurological deficits; * Amputation of the contralateral limb; * Active infections; * Immunodeficiency; * Comorbidities/concurrent disabilities, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), that may interfere with the study; * Presence of uncontrolled psychiatric comorbidities; * Declared or evident cognitive deficits that would impair understanding of the tasks required (MMSE ≤ 24); * Insufficient degree of cooperation; * Length of the bone stump (measured from the lesser trochanter to the apex of the stump) less than 15 cm; * Previous radiotherapy on the amputated limb; * Ongoing chemotherapy treatments. Relative exclusion criteria: * Smoking; * Uncontrolled diabetes; * Previous infections; * Presence of additional joint prostheses on the same limb; * Osteoporosis with a T-score of -2.5 or lower.
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What it tests

  • osseointegrated surgery for transfemoral amputation
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Where

1 site
IRCCS Rizzoli Orthopedic Institute
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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