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

• ClinicalTrials.gov Identifier: NCT04784429
• Recruitment Status: Active, not recruiting
• First Posted: March 5, 2021
• Last Update Posted: November 17, 2022
• Sponsor: Otto Bock Healthcare Products GmbH
• Collaborator: Hanger Clinic: Prosthetics & Orthotics
• Information provided by (Responsible Party): Otto Bock Healthcare Products GmbH

Tracking Information

• First Submitted Date: March 2, 2021
• First Posted Date: March 5, 2021
• Last Update Posted Date: November 17, 2022
• Actual Study Start Date: June 11, 2021
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 2, 2021)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 2, 2021)

• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
• Official Title: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Lower Limb Amputation Above Knee (Injury)
• Congenital Amputation of Lower Limb
• Lower Limb Amputation Knee

Intervention

• 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.
• Device: Non microprocessor controlled knee (NMPK)
  NMPK consistent with current standards of care

Study Arms

• Experimental: MPK
  Microprocessor controlled knee
  Intervention: Device: Kenevo or C-Leg 4
• Active Comparator: NMPK
  Non-microprocessor controlled knee
  Intervention: Device: Non microprocessor controlled knee (NMPK)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 16, 2022): 107
• Original Estimated Enrollment (submitted: March 2, 2021): 100
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04784429
• Other Study ID Numbers: OB113
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Otto Bock Healthcare Products GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Otto Bock Healthcare Products GmbH
• Original Study Sponsor: Same as current
• Collaborators: Hanger Clinic: Prosthetics & Orthotics

Investigators

• Principal Investigator: Andreas Kannenberg, MD, PhD; Otto Bock Healthcare Products GmbH
• Principal Investigator: Shane Wurdeman, PhD; Hanger Clinic: Prosthetics & Orthotics

• PRS Account: Otto Bock Healthcare Products GmbH
• Verification Date: November 2022