Comparing two types of prosthetic feet for transtibial amputees
Prospective, Multicentric, Comparative, Randomized, Cross-over Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot
This study is testing whether a new type of prosthetic foot can help people who have had a leg amputated below the knee move better and feel more comfortable compared to a standard prosthetic foot they've been using.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Össur Iceland ehf Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06627361 on ClinicalTrials.gov |
What this trial studies
This study evaluates the mobility of transtibial amputee patients using the innovative PRO-FLEX PIVOT® foot compared to a Class III Energy Storing and Returning (ESAR) prosthetic foot. The PRO-FLEX PIVOT® foot features advanced technology that allows for enhanced ankle movement and stability, aiming to improve the overall mobility of users. Participants will be assessed based on their functional performance and comfort while using these prosthetic devices. The study involves adult unilateral tibial amputees who have been using a Class III ESAR foot for at least six months.
Who should consider this trial
Good fit: Ideal candidates are adult unilateral tibial amputees who have been using a Class III ESAR foot for over six months.
Not a fit: Patients with bilateral lower limb amputations or those using temporary prostheses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for transtibial amputees.
How similar studies have performed: Other studies have shown promising results with similar prosthetic technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patient (over 18 years of age) * Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot. * Regularly using (more than 8 hours/day) a class III ESAR foot * Functional class (CNEDiMTS indication)1 * Insured person. * Able to answer questionnaires. * Providing informed and written consent to participate in the study. * Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation. * Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score) Exclusion Criteria: * Bilateral lower limb amputation * Femoral amputation * Wearing a temporary prosthesis * Change of socket or suspension system planned during the study. * Change of any functional component as torsion or choc adapter * Significant change in the patient's routine activities expected during the study. * Progressive associated pathology that may prevent patient follow-up. * Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... ) * No osteointegration patients * Lack of consent * Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research. * Person not affiliated with or a beneficiary of a health insurance plan. * Patient unable to understand the study instructions
Where this trial is running
Multiple Locations
- Multiples locations — Multiple Locations, France (Recruiting)
Study contacts
- Principal investigator: Noël MARTINET, PhD — IRR - Établissement de Nancy - Louis-Pierquin
- Study coordinator: Renaud URBINELLI
- Email: etudes@clin-experts.fr
- Phone: 0756882093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.