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

NCT06522646 | Completed DMC

• 1 other identifier: SPCM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.

  The aim is to compare the adaptation of the prosthetic system to the constraints of everyday life. SPCM adapts the ankle's behavior to the walking situation, and should make it possible to restore the time during which the foot remains flat during the stance phase, in different situations

  Evaluation after 4 weeks' wear of each of the 2 prostheses

Secondary Outcomes (9)

• Contralateral ankle power

  Evaluation after 4 weeks' wear of each of the 2 prostheses

• Pelvis elevation

  Evaluation after 4 weeks' wear of each of the 2 prostheses

• Toe clearance

  Evaluation after 4 weeks' wear of each of the 2 prostheses

• Prosthesis evaluation

  Evaluation after 4 weeks' wear of each of the 2 prostheses

• Locomotor abilities

  Evaluation after 4 weeks' wear of each of the 2 prostheses

Study Arms (2)

SPCM

EXPERIMENTAL

Patients will be fitted with the SPCM prothesis

Device: SPCM

Usual Prosthesis

ACTIVE COMPARATOR

Patients will be fitted with their usual microprocessor prosthesis

Device: Usual Prothesis

Interventions

SPCM DEVICE

During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis

SPCM

Usual Prothesis DEVICE

During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis

Usual Prosthesis

Eligibility Criteria

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

You may qualify if:

• Amputee at or above knee level
• Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
• Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
• Person able to understand simple commands, to read and write, and to give their informed consent
• Person who has given informed consent
• Person affiliated to a social security scheme

You may not qualify if:

• Minor
• Person of full age subject to a legal protection measure or unable to express consent
• Pregnant or breast-feeding women
• Persons with bilateral amputations
• Person with a neurological or orthopedic pathology with major repercussions on locomotion
• Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
• Persons weighing more than 125 kg
• Foot size less than 24 cm or greater than 30 cm
• Person with a hip disarticulation
• Person without an emergency walking solution
• Person with a suspension fitting with vacuum pump
• Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.

Sponsors & Collaborators

• Institution Nationale des Invalides: lead
• Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est: collaborator
• Hopital d'instruction des armées Percy (HIA Percy): collaborator
• Proteor Group: collaborator
• Direction Générale de l'Armement: collaborator

Study Sites (4)

Hôpital d'Instruction des Armées (HIA) Percy

Clamart, 92140, France

Location

UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy

Nancy, 54000, France

Location

Insitution Nationale des Invalides

Paris, 75007, France

Location

Institut de Biomécanique Humaine Georges Charpak

Paris, 75013, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: July 9, 2018
• Primary Completion: April 19, 2023
• Study Completion: May 31, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)