- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473992
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
December 7, 2023 updated by: Jason Highsmith
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Prosthetic knee 1 (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).
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Amputees' preferred prosthetic knee.
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Active Comparator: Prosthetic knee 2 (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)
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Study knee.
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No Intervention: Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects.
There are no interventions in this observational arm of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
75 Meter Self Selected Walking Test
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.
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Time to Complete a 75 meter walking distance.
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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.
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Physical Functional Performance (Continuous Scale; 10-items)
Time Frame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
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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.
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Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance and Stability
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.
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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.
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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.
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Prosthesis Evaluation Questionnaire: Utility Score.
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.
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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).
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Jason Highsmith, PT,DPT,CP, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
May 31, 2011
First Submitted That Met QC Criteria
November 14, 2011
First Posted (Estimated)
November 17, 2011
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 6140101200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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