AmputationAmputation; Traumatic, Leg, LowerLimb; Absence, Congenital, LowerProsthesis UserLower Limb Amputation Above Knee (Injury)Amputation; Traumatic, Leg: Thigh, Between Hip and Knee
Investigational drug(s) / intervention(s)
Ossur Power KneeReboocon Intuy Knee
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Are at least 18 years old
* Transfemoral prosthesis user (limb absence between the knee and hip)
* Current user of a mechanical knee
* Regularly wears prosthesis at least 5 days per week
* Have adequate clearance between distal end and ground for necessary knee and foot components
* Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team
* Socket-Comfort Score: 6 or above to ensure adequate socket fit
* Six months or more experience on a prosthesis
* Body weight between 50kg and 116kg (110lbs - 256lbs)
* Height between 1.2m and 1.95m (47.2in and 76.8in)
* Has a phone to answer periodic study calls
Exclusion Criteria:
* Present injuries to residual limb or contralateral leg affecting functional ability
* Contralateral amputation proximal to MTP (metatarsophalangeal) joint
* Socket issues/changes in the last 6 weeks
* Users with bone-anchored implants
* Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and/or completing the study
Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).
If subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.
Using a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
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)
Facility
City
Region
Status
Hanger Clinic
Austin
Texas
Recruiting
More Liberating Technologies, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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