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Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation (OPK)

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ClinicalTrials.gov Identifier: NCT02219230
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : December 28, 2015
Sponsor:
Collaborator:
Össur Ehf
Information provided by (Responsible Party):
Brian Hafner, University of Washington

Brief Summary:
The goals of this study are to assess measured, observed, and self-reported outcomes achieved through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological) prosthetic knee control systems in individuals with unilateral, transfemoral amputation.

Condition or disease Intervention/treatment Phase
Transfemoral Amputation Device: Active knee (Ossur Power Knee II) Device: Adaptive knee (Ossur Rheo) Device: Passive knee (Various manufacturers) Not Applicable

Detailed Description:
An interrupted time-series trial with pre/post baseline assessments, randomized crossover of interventions, and within-phase repeated measures is used to evaluate and compare the effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental protocol is applied to verify study participants receive appropriate training, experience, and assessment in each knee condition. A suite of standardized and ad-hoc physical performance tests, patient-reported questionnaires, and monitoring technologies were carefully selected to assess important, clinically-relevant participant outcomes. Comparative effectiveness of three prosthetic knee interventions are evaluated using direct measurement (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality) and self-report instruments (i.e., health status surveys). Analyses will focus on identifying differences between control system technologies inherent to each type of prosthetic knee (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes will be used to establish recommendations for which activities and patients knees are most appropriate or likely to produce a desired effect.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial
Study Start Date : June 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Prosthetic knee
Subjects crossed over between interventions (three different prosthetic knees). Knee conditions include 1) Active knee (Ossur Power Knee II); 2) Adaptive knee (Ossur Rheo); and 3) Passive knee (Various manufacturers)
Device: Active knee (Ossur Power Knee II)
Prosthetic knee with active control system.
Other Names:
  • Power knee
  • Motorized knee

Device: Adaptive knee (Ossur Rheo)
Prosthetic knee with adaptive control system.
Other Names:
  • Magnetorheological knee
  • Microprocessor knee

Device: Passive knee (Various manufacturers)
Prosthetic knee with mechanical control system.
Other Names:
  • Mechanical knee
  • Hydraulic knee
  • Pneumatic knee




Primary Outcome Measures :
  1. Timed Up and Go [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.

  2. Timed Ramp Test [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Timed performance test that involves walking up and down a 14ft ramp.

  3. Timed Stair Test [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Timed performance test that involves walking up and down 6 steps.

  4. Step activity [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Average daily step counts measured by an accelerometer-based device.

  5. Obstacle course time [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Time to walk a 1/2-mile outdoor walking course.


Secondary Outcome Measures :
  1. Reported Falls [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Self-report phone survey.

  2. Prosthesis Evaluation Questionnaire (PEQ) [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Self-report computerized survey (12 questions)

  3. Activities Specific Balance Confidence Scale (ABC) [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Self-report computerized survey (18 questions).

  4. Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Change from Baseline (mean score at weeks 1, 2, 3, and 4) to Follow-Up (mean score at weeks 8, 12, 16, 20, 24, and 28) ]
    Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 45 - 75
  • body weight less than 275lbs
  • unilateral amputation between the hip and knee
  • amputation due to non-vascular causes
  • no other major limb amputations
  • amputation occurred at least 2 years prior
  • stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket)
  • intact skin tissue without open wounds or sores for at least 2 months
  • physiologically stable medical condition (i.e., non-degenerative)
  • possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with non-microprocessor (i.e., mechanical or fluid) stance control
  • Medicare functional classification level (MFCL or "K-level") 3

Exclusion Criteria:

  • expect to receive or are expected to require a replacement prosthetic socket within 15 months
  • complete reliance on an assistive device (i.e., cane or walker) for ambulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219230


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Össur Ehf
Investigators
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Principal Investigator: Brian Hafner, PhD University of Washington
Additional Information:
Publications of Results:
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Responsible Party: Brian Hafner, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02219230    
Other Study ID Numbers: 40660-A
A62089 ( Other Identifier: University of Washington )
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015