Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

Jason Highsmith25 enrolled

Overview

The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Other and Unspecified Complications of Amputation Stump

Interventions

Otto Bock C-LegDEVICE

Amputees' preferred prosthetic knee.

Otto Bock GeniumDEVICE

Study knee.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Unilateral transfemoral or knee-disarticulation amputee * 18 to 85 years of age * K3 (variable cadence and community) ambulators; * Current use of and experience with the C-Leg for at least 1 year * Ability to descend stairs and hills without caregiver and assistive devices * Be able to independently provide informed consent * Be willing to comply with study procedures. Exclusion criteria: * History of chronic skin breakdown on the residual limb * Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking) * Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate * Unwillingness/inability to follow instructions

Locations (1)

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

75 Meter Self Selected Walking Test

Time to Complete a 75 meter walking distance.

Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

Physical Functional Performance (Continuous Scale; 10-items)

Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.

Time frame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.

Secondary Outcomes

Balance and Stability

Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.

Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

Prosthesis Evaluation Questionnaire: Utility Score.

The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).

Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

Data from ClinicalTrials.gov

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