The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.
During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Orthopedic Rehabilitation Center SKA Zicksee
Sankt Andrä am Zicksee, Burgenland, Austria
University Leuven
Pellenberg, Belgium
Change in 6 Minute Gait Test
A measure of walking endurance, the distance walked in meters after 6 minutes.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in 10 Meter Gait Test
Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Stairs Assessment Index (SAI)
Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Hill Assessment Index (HAI)
Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Four Step Square Test (FSST)
Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Activities-specific Balance Confidence (ABC) Scale
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Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)
The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample (i.e., people with unilateral amputation).
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Amputee Body Image Scale (ABIS)
The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Number of Stumbles and Falls
Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?"
Time frame: At 3rd study visit after having been fitted and acclimatized to each of the study devices