Assessment of patients with transfemoral amputation using osseointegrated implants

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

This study is testing if a new type of implant that attaches directly to the bone can help people with transfemoral amputation move better and feel more comfortable than traditional prosthetic sockets.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bologna)
• Trial ID: NCT06737770 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with unilateral transfemoral amputation who struggle with traditional prostheses.

Not a fit: Patients with peripheral vascular diseases, active infections, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life for amputees by reducing complications and improving mobility.

How similar studies have performed: Previous studies on osseointegration have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

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 this trial is running

Bologna

• IRCCS Rizzoli Orthopedic Institute — Bologna, Italy (Recruiting)

Conditions Prosthesis; Lower Limb Amputation Knee; Amputation; Traumatic, Leg, Lower; Osseointegration