NCT06522646|CompletedDMC
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
SPCM
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SPCM
Sponsor study identifier
interventional
12
1 country
4
Study Start
July 9, 2018
Actual (reported)Primary Completion
April 19, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2018
Actual (reported)April 19, 2023
Actual (reported)May 31, 2023
Actual (reported)July 16, 2024
Actual (reported)July 26, 2024
Actual (reported)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
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
Patients will be fitted with the SPCM prothesis
Patients will be fitted with their usual microprocessor prosthesis
During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis
During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis
Hôpital d'Instruction des Armées (HIA) Percy
Clamart, 92140, France
UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy
Nancy, 54000, France
Insitution Nationale des Invalides
Paris, 75007, France
Institut de Biomécanique Humaine Georges Charpak
Paris, 75013, France
12 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2024
First Posted
July 26, 2024
Study Start
July 9, 2018
Actual (reported)Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 19, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Last Updated
July 26, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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