At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating 3C60-NMPK and NMPK-3C60 for Amputation of Hip and Thigh, Level Unspecified. Completed, enrolled 35 participants across 15 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
3 months with 3C60 - 10 days wash out - 1 month with NMPK
1 month with NMPK - 3 months with 3C60