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

Össur Ehf1 site in 1 country30 target enrollmentNovember 22, 2023

ConditionsAmputation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Amputation
Sponsor: Össur Ehf
Enrollment: 30
Locations: 1
Primary Endpoint: Change of mobility of the patient
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:

The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.

The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.

Registry

clinicaltrials.gov

Start Date

November 22, 2023

End Date

March 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Össur Ehf

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change of mobility of the patient

Time Frame: 28 days

Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-M™) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility)