Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627361
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFI
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None