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New treatment option for Prosthesis
Official title Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant
ClinicalTrials.gov ID: NCT06737770
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people of both sexes, aged between 18 and 65 years;
- people with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect;
- people 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...
You likely can't join if
- Peripheral vascular diseases;
- Pregnancy;
- Rheumatoid arthritis;
- Neurological deficits;
- Amputation of the contralateral limb;
- Active infections;
See the full eligibility criteria
- people of both sexes, aged between 18 and 65 years;
- people with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect;
- people 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);
- people who have signed informed consent and reviewed the study information sheet. Absolute
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.