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Transfemoral AmputationOPKNCT02219230

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

A study testing Active knee (Ossur Power Knee II), Adaptive knee (Ossur Rheo) and Passive knee (Various manufacturers) in people with Transfemoral Amputation, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Transfemoral Amputation
What is being tested?
Active knee (Ossur Power Knee II), Adaptive knee (Ossur Rheo) and Passive knee (Various manufacturers)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Jun 2011to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Outcomes Associated With Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation: a Randomized Crossover Trial

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.

Read the 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.

Being tested
Active knee (Ossur Power Knee II), Adaptive knee (Ossur Rheo), Passive knee (Various manufacturers)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active knee (Ossur Power Knee II)Device

    Also called Power knee, Motorized knee

    Prosthetic knee with active control system.

  • Adaptive knee (Ossur Rheo)Device

    Also called Magnetorheological knee, Microprocessor knee

    Prosthetic knee with adaptive control system.

  • Passive knee (Various manufacturers)Device

    Also called Mechanical knee, Hydraulic knee, Pneumatic knee

    Prosthetic knee with mechanical control system.

Study groups in NCT02219230
Study groupRoleWhat they receive
Prosthetic kneeExperimentalSubjects 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)
Receives: Device: Active knee (Ossur Power Knee II); Device: Adaptive knee (Ossur Rheo); Device: Passive knee (Various manufacturers)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed Up and Go

    Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.

    Measured: 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)

  2. Timed Ramp Test

    Timed performance test that involves walking up and down a 14ft ramp.

    Measured: 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)

  3. Timed Stair Test

    Timed performance test that involves walking up and down 6 steps.

    Measured: 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)

  4. Step activity

    Average daily step counts measured by an accelerometer-based device.

    Measured: 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)

  5. Obstacle course time

    Time to walk a 1/2-mile outdoor walking course.

    Measured: 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)

Secondary outcomes (4)

  1. Reported Falls

    Self-report phone survey.

    Measured: 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)

  2. Prosthesis Evaluation Questionnaire (PEQ)

    Self-report computerized survey (12 questions)

    Measured: 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)

  3. Activities Specific Balance Confidence Scale (ABC)

    Self-report computerized survey (18 questions).

    Measured: 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)

  4. Patient Reported Outcomes Measurement Information System (PROMIS)

    Self-report computerized questionnaire with 8-14 questions per domain. Includes Physical Function, Fatigue, and General Health subdomains.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2014 (estimated)
  2. Study startJun 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219230
Sponsor's protocol ID
40660-A
Other IDs
A62089
Acronym
OPK
Status last verified
Dec 2015
First submitted
29 Jul 2014
Last updated
28 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Hafner BJ, Askew RL. Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. J Rehabil Res Dev. 2015;52(6):677-700. doi: 10.1682/JRRD.2014.09.0210.

    PubMed 26560243

Questions about this trial

What is this clinical trial studying?

A study testing Active knee (Ossur Power Knee II), Adaptive knee (Ossur Rheo) and Passive knee (Various manufacturers) in people with Transfemoral Amputation, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219230, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.

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