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

NCT06737770 | Recruiting

• 1 other identifier: OSTEO-OUTCOME
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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 limb and long-term weight fluctuations further complicate the use of conventional prostheses. In the last two decades, research groups, assisted by experienced surgeons, have worked to develop implant solutions that bypass the socket and address these issues. One such solution is osteointegrated prostheses, which use the principle of osteointegration to anchor the prosthesis directly to the bone of the residual limb. A metal stem is surgically inserted into the medullary canal of the residual limb and fixed through bone growth, establishing a direct connection between the amputated limb and the external prosthesis. Osteointegrated prostheses are widely accepted worldwide as a valid alternative to socket prostheses, especially for young and active individuals with transfemoral, transtibial, transhumeral, or transradial amputations not caused by vascular issues. The key benefit of osteointegration is the restoration of load alignment along the anatomical and mechanical axis, improving control of the residual limb during walking, as well as overall functional capacity and quality of life. Other advantages include greater stability, enhanced sitting comfort, a wider range of hip movement, faster attachment and detachment of the prosthesis, and improved body perception. Additionally, the direct contact between the metal stem and the bone generates sensory feedback (osteoperception), allowing the patient to better control the amputated limb by perceiving ground contact through vibrations transmitted to the bone. Osteointegration offers the only viable alternative for prosthetic use in patients with a short residual limb, where conventional socket prostheses would not be suitable.

Conditions

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

Keywords

Osseointegration

Outcome Measures

Primary Outcomes (1)

• EQ-5D-5L

  It is a generic tool for measuring perceived quality of life in relation to health status, divided into 5 domains, each assigned a score ranging from 1 (best possible outcome) to 5 (worst possible outcome): mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Additionally, there is a domain related to general health, scored from 0 (worst possible health status) to 100 (best possible health status)

  12 months after surgery

Secondary Outcomes (6)

• Q-TFA

  12 months after surgery

• VAS

  12 months after surgery

• ABIS

  12 months after surgery

• TAPES

  12 months after surgery

• PWB-PTCQ

  12 months after surgery

Study Arms (1)

patients undergoing osseointegration surgery for transfemoral amputation

EXPERIMENTAL

Procedure: osseointegrated surgery for transfemoral amputation

Interventions

osseointegrated surgery for transfemoral amputation PROCEDURE

osseointegrated surgery for transfemoral amputation

patients undergoing osseointegration surgery for transfemoral amputation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Smoking;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 17, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

IT (1)