NCT06522646

Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Institution Nationale des Invalides · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis". The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people. This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.

Conditions

• Amputation
• Lower Limb Amputation Above Knee (Injury)

Interventions

Type	Name	Description
DEVICE	SPCM	During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis
DEVICE	Usual Prothesis	During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis

Timeline

• Start date: 2018-07-09
• Primary completion: 2023-04-19
• Completion: 2023-05-31
• First posted: 2024-07-26
• Last updated: 2024-07-26

Locations

4 sites across 1 country: France