Feasibility study on osteoarthritis prevalence of amputees fitted with microprocessor controlled knee joints compared to mechanical systems

• Conditions: M15-M19; M54.9; Arthrosis; Dorsalgia, unspecified

• Registration Number: DRKS00017435
• Lead Sponsor: Ottobock SE & Co. KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-12
• Study Completion: 2020-12-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• Patient is 40-80 year old
• Patient is male
• Patient is able to express the consent for the study independently
• Patient agree with the course of the study
• Patient is transfemoral amputated or kneedisarticulated
• the Amputation is unilateral
• Patient has at least mobility 2
• Patient is at least amputated since 5 years at the beginning of the analysis
• Patient use the appropriate knee Joint 3 years at the beginning of the analysis

Exclusion Criteria

• Patient with socket problems restricting mobility
• Patients with diagnosed orthopaedic and neurologic impairments on the non amputated side independently of the amputation
• Patient is not able/ won't attend the orders
• Using a transverse-oval prosthetic socket
• Using a microprocessor controlled foot

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome is the prevalence of clinical Symptoms of knee osteoarthritis on the sound side using the ACR criteria amputees with and without MPK

Secondary Outcome Measures

Name	Time	Method
Secundary Outcomes are clinical signs of hip, knee-, ankle- and foot osteoarthritis, backpain, patients mobility, biomechanical parameters for walking on level ground, stairs and ramps.