Assessment of patients with transfemoral amputation using osseointegrated implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of osseointegrated implants for patients with transfemoral amputation, aiming to improve mobility and quality of life. The study focuses on individuals who experience difficulties with traditional socket prostheses, which often lead to skin complications and discomfort. Participants will undergo osseointegrated surgery, which directly anchors the prosthesis to the bone, potentially alleviating common issues associated with conventional prosthetic devices. The trial will assess both clinical outcomes and functional performance post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Rizzoli Orthopedic Institute
  Bologna, Bologna, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.