Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Condition(s) studied

Investigational drug(s) / intervention(s)

Ossur Power Knee: Newest version of the commercially-available powered knee developed by Ossur.

Reboocon Intuy Knee: Commercially-available powered knee developed by Reboocon.

Study summary

The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.

Eligibility

Primary outcome measure(s)

• Step count — Monitored over entire study (9 months)
  Prior to each condition, each subject will be fit and aligned on the designated knee by a trained certified prosthetist. An activity monitor (such as the GeneActiv™) will be worn by the subject during each 3 month intervention period. Similar to prior studies, the investigators will use the activity monitor to track the number of steps the subjects take in each condition. A higher step count is a better outcome.
• Activities-Specific Balance Confidence scale (ABC) - Measuring change from baseline — Throughout study completion, an average of 9 months
  The ABC is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing activities, from 0 (no confidence) to 4 (complete confidence). A higher score means a better outcome. This survey will be given at the beginning and end of each study condition (3 conditions, 3 months per condition). Additionally, this survey will be given at the subject's last training session, which is dependent on the subject's scheduling availability and proficiency with each knee condition. The subject will have between 4-8 training sessions per condition until deemed proficient or the 8th session has been completed, whichever comes first. All training sessions are expected to be completed within the first month of each condition. This survey will be administered as a part of the master questionnaire.
• Prosthesis Evaluation Questionnaire - Well Being (PEQ-WB) - Measuring change from baseline — Throughout study completion, an average of 9 months
  The version of the PEQ which will be administered consists of 2 questions in 1 category (well being). For purposes of easier administration, the investigators have adopted the modified 10-point ordinal scale version of the PEQ-WB (scale 1-10, where a higher score is a better outcome). This survey will be given at the beginning and end of each study condition (3 conditions, 3 months per condition). Additionally, this survey will be given at the subject's last training session, which is dependent on the subject's scheduling availability and proficiency with each knee condition. The subject will have between 4-8 training sessions per condition until deemed proficient or the 8th session has been completed, whichever comes first. All training sessions are expected to be completed within the first month of each condition. This survey will be administered as a part of the master questionnaire.

Trial sites (1)

More Liberating Technologies, Inc. trials in the USA

Other trials for the same condition