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

This study has been completed.
Sponsor:
Collaborators:
Otto Bock Healthcare
Florida High Tech Corridor Council.
Information provided by (Responsible Party):
Jason Highsmith, University of South Florida
ClinicalTrials.gov Identifier:
NCT01473992
First received: May 31, 2011
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Other and Unspecified Complications of Amputation Stump
Device: Otto Bock C-Leg
Device: Otto Bock Genium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Time to Complete a 75 meter walking distance.

  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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).


Enrollment: 25
Study Start Date: January 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Device: Otto Bock C-Leg
Amputees' preferred prosthetic knee.
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)
Device: Otto Bock Genium
Study knee.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473992

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Jason Highsmith
Otto Bock Healthcare
Florida High Tech Corridor Council.
Investigators
Principal Investigator: M. Jason Highsmith, PT,DPT,CP University of South Florida
  More Information

No publications provided

Responsible Party: Jason Highsmith, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01473992     History of Changes
Other Study ID Numbers: 6140101200
Study First Received: May 31, 2011
Results First Received: May 6, 2014
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014