Clinical trial NCT06627361: Comparative 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: Lower limb amputation
Mobility
Pro-Flex Pivot
Randomized
ESAR foot
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

1. 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.
2. 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.
3. 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.


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
* 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

Primary outcomes:
measure: Change of mobility of the patient
timeFrame: 28 days
Secondary outcomes:
measure: Variations in comfort experienced during the wearing of the foot
timeFrame: 28 days
measure: Change in quality of life
timeFrame: 28 days
measure: Change in satisfaction of the patient
timeFrame: 28 days
measure: Occurence of falls
timeFrame: 28 days
measure: Number of patients with technical incidents
timeFrame: 28 days
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiples locations
Study officials:
affiliation: IRR - Établissement de Nancy - Louis-Pierquin
name: Noël MARTINET, PhD
role: PRINCIPAL_INVESTIGATOR
References: