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.

NCT06627361 | Unknown

• 1 other identifier: 2023-A01374-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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.

Conditions

Amputation

Keywords

Lower limb amputation; Mobility; Pro-Flex Pivot; Randomized; ESAR foot

Outcome Measures

Primary Outcomes (1)

• Change of mobility of the patient

  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)

  28 days

Secondary Outcomes (5)

• Variations in comfort experienced during the wearing of the foot

  28 days

• Change in quality of life

  28 days

• Change in satisfaction of the patient

  28 days

• Occurence of falls

  28 days

• Number of patients with technical incidents

  28 days

Study Arms (2)

PRO-FLEX PIVOT

EXPERIMENTAL

The patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days

Device: PRO-FLEX PIVOT Foot evaluation

Class III ESAR foot

ACTIVE COMPARATOR

The patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days

Device: Class III ESAR Foot evaluation

Interventions

PRO-FLEX PIVOT Foot evaluation DEVICE

The subject will wear the PRO-FLEX PIVOT foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test

PRO-FLEX PIVOT

Class III ESAR Foot evaluation DEVICE

The subject will wear his usual Class III ESAR Foot foot for 4 weeks, following which they will complete questionnaires and undergo a Time Up and Go test

Class III ESAR foot

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiples locations

Multiple Locations, France

RECRUITING

Study Officials

• Noël MARTINET, PhD

  IRR - Établissement de Nancy - Louis-Pierquin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud URBINELLI

CONTACT

0756882093; etudes@clin-experts.fr

Noël MARTINET, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 4, 2024
• Study Start: November 22, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)