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Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population (ASCENT K2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04784429
Recruitment Status : Active, not recruiting
First Posted : March 5, 2021
Last Update Posted : November 17, 2022
Sponsor:
Collaborator:
Hanger Clinic: Prosthetics & Orthotics
Information provided by (Responsible Party):
Otto Bock Healthcare Products GmbH

Study Description
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Brief Summary:
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Above Knee (Injury) Congenital Amputation of Lower Limb Lower Limb Amputation Knee Device: Kenevo or C-Leg 4 Device: Non microprocessor controlled knee (NMPK) Not Applicable

Detailed Description:
Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Actual Study Start Date : June 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MPK
Microprocessor controlled knee
 Device: Kenevo or C-Leg 4
Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.
Active Comparator: NMPK
Non-microprocessor controlled knee
 Device: Non microprocessor controlled knee (NMPK)
NMPK consistent with current standards of care


Outcome Measures
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Primary Outcome Measures :
  1. Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [ Time Frame: 12 months ]
    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

  2. Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [ Time Frame: 5 years ]
    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [ Time Frame: 12 months ]
    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: 12 months ]
    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  3. 12-month fall count from bi-weekly fall journal [ Time Frame: 12 months ]
    On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.

  4. Average daily step counts [ Time Frame: 12 months ]
    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

  5. Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [ Time Frame: 3 years ]
    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [ Time Frame: 5 years ]
    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: 5 years ]
    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  8. 10-meter Walk Test (10mWT) [ Time Frame: 5 years ]
    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

  9. Timed Up and Go (TUG) [ Time Frame: 5 years ]
    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [ Time Frame: 3 years ]
    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

  11. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: 3 years ]
    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  12. 10-meter Walk Test (10mWT) [ Time Frame: 3 years ]
    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

  13. Timed Up and Go (TUG) [ Time Frame: 3 years ]
    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral transfemoral or knee disarticulation amputation
  • Received prosthesis between 4 - 24 months prior
  • Currently uses prosthesis
  • K2 ambulator status
  • Able to speak English or Spanish language
  • Age ≥ 65 years at Baseline Assessment (one month after enrollment)
  • Minimum Socket Comfort Score (SCS) of 6/10

Exclusion Criteria:

  • Upper limb involvement
  • Individuals ≥ 275 lbs
  • Unable to provide informed consent
  • History of acute or chronic residual limb breakdown
  • History of 2 or more socket adjustments or replacements in the past 6 months
  • Amputation of the contralateral limb
  • Active malignancy
  • Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel
  • Patient unable or unwilling to follow study procedures
  • Pregnant women, institutionalized persons, and children
Contacts and Locations
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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): NCT04784429


Locations
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Sponsors and Collaborators
Otto Bock Healthcare Products GmbH
Hanger Clinic: Prosthetics & Orthotics
Investigators
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Principal Investigator: Andreas Kannenberg, MD, PhD Otto Bock Healthcare Products GmbH
Principal Investigator: Shane Wurdeman, PhD Hanger Clinic: Prosthetics & Orthotics
More Information
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Responsible Party: Otto Bock Healthcare Products GmbH
ClinicalTrials.gov Identifier: NCT04784429    
Other Study ID Numbers: OB113
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otto Bock Healthcare Products GmbH:
Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2