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

This study is currently recruiting participants.
Verified July 2012 by University of South Florida
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: July 17, 2012
Last verified: July 2012
History of Changes
  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:

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

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.


Estimated Enrollment: 25
Study Start Date: January 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (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

Contacts
Contact: M. Jason Highsmith, PT,DPT,CP 813-974-3806 mhighsmi@health.usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: M. Jason Highsmith, PT, DPT, CP            
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: July 17, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013