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Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-17
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Limb amputation greatly reduces daily activity ability, mobility, and quality of life. In Italy, many people live with motor disabilities, and lower limb amputations mostly affect elderly individuals due to diabetes or vascular causes, as well as middle-aged adults from accidents and young people from traffic incidents. Traditional prostheses use sockets that often cause chronic skin problems and discomfort. To address these issues, research has developed osteointegrated prostheses, which connect the prosthesis directly to the bone, bypassing the socket and improving limb function. This study evaluates the use of osteointegrated implants in patients with transfemoral amputation. The implant involves surgically inserting a metal stem into the residual bone, allowing bone growth to secure the prosthesis. This method aims to improve load alignment, stability, comfort, and sensory feedback compared to conventional socket prostheses. The study focuses on adults aged 18 to 65 with unilateral transfemoral amputation from trauma, tumor, infection, or congenital defects who have difficulty using traditional sockets. Participants will undergo osteointegrated prosthesis surgery and be followed for at least 12 months. Researchers will assess quality of life and function using several tools, including the EQ-5D-5L, Q-TFA, and others. The study will monitor pain, functional ability, body image, and disability levels. Safety and cooperation will be evaluated, with regular assessments throughout the follow-up period. The study aims to understand the clinical and functional outcomes of this implant method in transfemoral amputees.
CONDITIONS
Brief Title
Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects of both sexes, aged between 18 and 65 years
- Unilateral transfemoral amputation due to trauma, tumor, infection, or congenital defect
- Already scheduled for osteointegrated prosthesis surgery
- Body mass index (BMI) less than 35 kg/m²
- Difficulty using traditional socket prosthesis (pain, reduced mobility, short residual limb, skin infections, ulcers, volume changes)
- Signed informed consent and reviewed study information
You will not qualify if you...
- Peripheral vascular diseases
- Pregnancy
- Rheumatoid arthritis
- Neurological deficits
- Amputation of the contralateral limb
- Active infections
- Immunodeficiency
- Comorbidities or disabilities such as Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms
- Uncontrolled psychiatric comorbidities
- Cognitive deficits impairing task understanding (MMSE ≤ 24)
- Insufficient cooperation
- Bone stump length less than 15 cm
- Previous radiotherapy on the amputated limb
- Ongoing chemotherapy
- Smoking
- Uncontrolled diabetes
- Previous infections
- Additional joint prostheses on the same limb
- Osteoporosis with a T-score of -2.5 or lower
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and following days as needed
Participants undergo osseointegrated surgery for transfemoral amputation and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits (in-person)
Duration - Up to 12 months after surgery
Participants are followed for recovery and functional assessment after surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
IRCCS Rizzoli Orthopedic Institute
Bologna, Italy, 40136
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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