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

Not Applicable

Completed

• Conditions: Other and Unspecified Complications of Amputation Stump
• Interventions: Device: Otto Bock C-Leg; Device: Otto Bock Genium

• Registration Number: NCT01473992
• Lead Sponsor: Jason Highsmith

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-05-06
• Results First Submitted QC: 2014-11-17
• Results First Posted: 2014-11-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prosthetic knee 1 (Otto Bock C-Leg)	Otto Bock C-Leg	This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).
Prosthetic knee 2 (Otto Bock Genium)	Otto Bock Genium	This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)

Primary Outcome Measures

Name	Time	Method
Physical Functional Performance (Continuous Scale; 10-items)	Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.	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.
75 Meter Self Selected Walking Test	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.	Time to Complete a 75 meter walking distance.

Secondary Outcome Measures

Name	Time	Method
Prosthesis Evaluation Questionnaire: Utility Score.	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.	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).
Balance and Stability	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.	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.

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States