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.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	PRO-FLEX PIVOT Foot evaluation	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
DEVICE	Class III ESAR Foot evaluation	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

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

1 site across 1 country: France