NCT02382991

Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)

Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Otto Bock France SNC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling. The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

Detailed description

The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing. After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.

Conditions

• Amputation of Hip and Thigh, Level Unspecified

Interventions

Type	Name	Description
DEVICE	3C60-NMPK	3 months with 3C60 - 10 days wash out - 1 month with NMPK
DEVICE	NMPK-3C60	1 month with NMPK - 3 months with 3C60

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-03-09
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

15 sites across 3 countries: Austria, France, Germany