MedTrace Logo

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

NCT06522646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

    collaborator OTHER

  • Hopital d'instruction des armées Percy (HIA Percy)

    collaborator UNKNOWN

  • Proteor Group

    collaborator INDUSTRY

  • Direction Générale de l'Armement

    collaborator UNKNOWN

  • Institution Nationale des Invalides

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2023-04-19
Completion
2023-05-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522646 on ClinicalTrials.gov