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Trial record 12 of 36 for:    Recruiting, Not yet recruiting, Available Studies | "Amputees"

C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

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ClinicalTrials.gov Identifier: NCT02765035
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Otto Bock Healthcare Products GmbH

Brief Summary:
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Above Knee (Injury) Device: C-Leg 4 Device: C-Leg 3 Phase 4

Detailed Description:
During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Cross-over Trial to Evaluate the Safety, Functional Mobility and Satisfaction of the Microprocessor Controlled Prosthetic Knee Component C-Leg 4 in Transfemoral Amputees
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: C-Leg 4/C-Leg 3
The participants will be firstly fitted with C-Leg 4 and then with C-Leg 3.
Device: C-Leg 4
Microprocessor Controlled Knee

Device: C-Leg 3
Microprocessor Controlled Knee

Experimental: C-Leg 3/C-Leg 4
The participants will be firstly fitted with C-Leg 3 and then with C-Leg 4.
Device: C-Leg 4
Microprocessor Controlled Knee

Device: C-Leg 3
Microprocessor Controlled Knee




Primary Outcome Measures :
  1. Change in 6 Minute Gait Test [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)


Secondary Outcome Measures :
  1. Change in 10 meter Gait Test [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  2. Change in Stairs Assessment Index (SAI) [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  3. Change in Hill Assessment Index (HAI) [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  4. Change in Four Step Square Test (FSST) [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  5. Change in Activities-specific Balance Confidence (ABC) Scale [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  6. Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  7. Change in Amputee Body Image Scale (ABIS) [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  8. Change in Number of stumbles and falls [ Time Frame: 0 day, week 4, week 6, week 18, week 22, week 26 ]
    Baseline measurements: at the 0 day, after 4 weeks, after 6 weeks of use of original knee joint; Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)

  9. Change in Preference of the knee [ Time Frame: week 18, week 22, week 26 ]
    Follow-up measurements: after up to 12 weeks of use of 1st microprocessor knee joint (MPK) (C-Leg3 or C-Leg4) (week 18), after 4 weeks of use of 2nd MPK (C-Leg 4 or C-Leg3) (week 22), after 4 weeks of use of re-fitted original knee joint (week 26)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person is >18 years old.
  • Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
  • Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
  • Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
  • Person was never fitted with microprocessor controlled prosthetic knee joint.
  • Person is willing and able to independently provide informed consent.
  • Person is willing to comply with study procedures.
  • Person wears prosthesis daily and ≥ 8 hours/day.
  • Person is walking on average 1km/day.
  • Person is walking not slower than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
  • Person is walking on level ground in a step over step manner.

Exclusion Criteria:

  • Person is under 18 years of age.
  • Person who weighs more than 136kg.
  • Person who weighs less than 50kg.
  • Person who is pregnant.
  • Person has a history of chronic skin breakdown on the residual limb.
  • Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
  • Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
  • Person is using under arm axillary crutches or walker.
  • Person in an emergency, life threatening situation.
  • Person is unwilling/unable to follow instructions.
  • Person who is not available to follow the entire study protocol.
  • Person who is participating in another study or intends to participate in another study during this study duration.
  • Person who cannot personally provide their consent.
  • Person who is not wearing prosthesis 8hours/day on average.
  • Person who has a score on 10m walk test less than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
  • Person who walks on average less than 1km per day.
  • Person who is not able to walk on level ground in a step over step manner.

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): NCT02765035


Contacts
Contact: Stephan Domayer, Prim.Dr. +4321762325123 stephan.domayer@skazicksee.at

Locations
Austria
Orthopedic Rehabilitation Center SKA Zicksee Recruiting
St. Andrä, Burgenland, Austria, 7161
Contact: Stephan Domayer, Prim.Dr.    +4321762325123    stephan.domayer@skazicksee.at   
Belgium
University Leuven Recruiting
Pellenberg, Belgium, 3212
Contact: Carlotte kiekens, Dr.    +32 16 33 87 00    carlotte.kiekens@uzleuven.be   
Sponsors and Collaborators
Otto Bock Healthcare Products GmbH
Investigators
Principal Investigator: Stephan Domayer, Prim.Dr. Orthopedic Rehabilitation Center

Responsible Party: Otto Bock Healthcare Products GmbH
ClinicalTrials.gov Identifier: NCT02765035     History of Changes
Other Study ID Numbers: PD-PS00120010A-001
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data for primary and secondary outcome measures will be made available within one year of study completion.