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

This study has been completed.
Sponsor:
Collaborator:
Otto Bock Healthcare
Information provided by (Responsible Party):
Jason Highsmith, University of South Florida
ClinicalTrials.gov Identifier:
NCT01473992
First received: May 31, 2011
Last updated: February 17, 2014
Last verified: February 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:
  • Gait [ 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: Yes ]
    Gait will be assessed in terms of biomechanics and spatiotemporal parameters.


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: Yes ]
    Balance and stability will be assessed for limits of stability and postural stability.

  • Quality of Life [ 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 ]
    Validated surveys will be used to solicit participants' subjective experience and feedback.


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 Device: Otto Bock C-Leg
Amputees' preferred prosthetic knee.
Active Comparator: Prosthetic knee 2 Device: Otto Bock Genium
Study knee.

  Eligibility

Ages Eligible for Study:   18 Years to 35 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
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
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
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 23, 2014