CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
C leg compared to subject's mechanical leg (Otto Bock) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01537211
NCT01537211N/ACompleted

Microprocessor Knee Versus Mechanical Knee: Impact on Functional Outcomes in Dysvascular Transfemoral Amputees

Shirley Ryan AbilityLab·interventional·Posted Feb 23, 2012·Updated Sep 6, 2019

In Brief

A clinical study evaluating C leg compared to subject's mechanical leg (Otto Bock) for Transfemoral Amputation and Unilateral Traumatic Amputation of Leg at or Above Knee. Completed, enrolled 10 participants across 1 site.

Detailed Summary

In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to assist with function, including a prosthetic knee and a prosthetic foot. Currently, dysvascular amputees are given a prosthetic knee based on the basic expectation that they will be functionally stable. This consideration does not address higher levels of function like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not able to counteract their co-morbidities with a more active lifestyle. Walking is less energy efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on different surfaces and at multiple cadences through better control in swing and stance phases of gait. The impact of the functional differences in the prostheses is not clear and requires additional investigation to clarify the choice of the most appropriate functional prosthesis. The purpose of this study is to compare the functional outcomes with the traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2012
Enrollment StartAug 1, 2011
Primary CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 14.4 years ago

Interventions

C leg compared to subject's mechanical leg (Otto Bock)device

comparison of different prosthetic knees

C leg compared to subject's mechanical leg (Otto Bock)device

comparison of different prosthetic knees