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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee; Congenital Amputation of Lower Limb
• Intervention / Treatment: Device: Kenevo or C-Leg 4; Device: Non microprocessor controlled knee (NMPK)

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
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Hanger Clinic - 321 Westgate Pkwy
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Hanger Clinic - 3501 S Mercy Road
    • Phoenix, Arizona, United States, 85014
      • Hanger Clinic - 3816 N. 7th St.
    • Phoenix, Arizona, United States, 85032
      • Hanger Clinic - 4045 E Bell Rd
    • Sun City West, Arizona, United States, 85375
      • Hanger Clinic - 13925 Meeker Blvd, Suite 5
  • California
    • Antioch, California, United States, 94531
      • Hanger Clinic - 4849 Lonetree Way, STE B
    • Folsom, California, United States, 95630
      • Hanger Clinic - 1743 Creekside, Suite #110
    • Sacramento, California, United States, 95816
      • Hanger Clinic - California - 1248 32nd St
    • Torrance, California, United States, 90505
      • Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7
    • Visalia, California, United States, 93227
      • Hanger Clinic - 820 S Akers St, Ste 230
    • Yuba City, California, United States, 95991
      • Hanger Clinic - 1215 Plumas Street, Suite 1000
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place
  • Florida
    • Brandon, Florida, United States, 33511
      • Hanger Clinic - 1119 Professional Park Drive
    • Daytona Beach, Florida, United States, 32117
      • Hanger Clinic - 1400 Mason Ave. Suite 103
    • Fort Myers, Florida, United States, 33919
      • Hanger Clinic - 12591 Creekside Lane
    • Inverness, Florida, United States, 34450
      • Hanger Clinic - 221 W. Main Street
    • Kissimmee, Florida, United States, 34744
      • Hanger Clinic - 308 East Oak Street
    • Naples, Florida, United States, 34109
      • Hanger Clinic - 6270 Naples Blvd, Bldg 1
    • Pensacola, Florida, United States, 32504
      • Hanger Clinic - 824 Creighton Road
    • Saint Augustine, Florida, United States, 32086
      • Hanger Clinic - 200 Southpark Blvd, Suite 209
    • Winter Haven, Florida, United States, 33880
      • Hanger Clinic - 215 First Street North, Suite 300A
  • Georgia
    • Albany, Georgia, United States, 31707
      • Hanger Clinic - 607 N. Jefferson Street
    • Cumming, Georgia, United States, 30041
      • Hanger Clinic - 1050 Buford Rd, Ste 106
    • Macon, Georgia, United States, 31201
      • Hanger Clinic - 778 Riverside Drive
    • Statesboro, Georgia, United States, 30458
      • Hanger Clinic - 1215A Merchant Way
  • Illinois
    • Alsip, Illinois, United States, 60803
      • Hanger Clinic - 11346 S Cicero Ave
    • Chicago, Illinois, United States, 60657
      • Hanger Clinic - 2835 N Sheffield Ave, Ste 301
    • Naperville, Illinois, United States, 60563
      • Hanger Clinic - 1551 Bond Street, Suite 111
    • Oak Park, Illinois, United States, 60304
      • Hanger Clinic - 401 Harrison Street
    • Springfield, Illinois, United States, 62702
      • Hanger Clinic - 355 W Carpenter St.
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Hanger Clinic - 4821 Old National Road East, Suite A
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Hanger Clinic - 4505 Utica Ridge Rd
    • Cedar Rapids, Iowa, United States, 52403
      • Hanger Clinic - 866 5th Ave SE
    • Des Moines, Iowa, United States, 50314
      • Hanger Clinic - 330 Laurel St. #1300
    • Fort Dodge, Iowa, United States, 50521
      • Hanger Clinic - 804 Kenyon Road
  • Kansas
    • Salina, Kansas, United States, 67401
      • Hanger Clinic - 645 East Crawford St
    • Wichita, Kansas, United States, 67214
      • Hanger Clinic - 410 N. Hillside, Suite 100
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hanger Clinic - 8522 Summa Ave
    • Lafayette, Louisiana, United States, 70508
      • Hanger Clinic - 940 Kaliste Saloom
  • Maine
    • Bangor, Maine, United States, 04401
      • Hanger Clinic - 1010 Stillwater Ave, Ste 106
    • Portland, Maine, United States, 04102
      • Hanger Clinic - 959 Brighton Ave.
  • Maryland
    • Towson, Maryland, United States, 21286
      • Hanger Clinic - 1001 Cromwell Bridge Rd, Suite 108
  • Massachusetts
    • Leominster, Massachusetts, United States, 01453
      • Hanger Clinic - 100 Erdman Way, STE 100
    • Methuen, Massachusetts, United States, 01844
      • Hanger Clinic - 100 Milk Street, Suite 120
    • Springfield, Massachusetts, United States, 01103
      • Hanger Clinic - 1985 Main Street
  • Michigan
    • Big Rapids, Michigan, United States, 48038
      • Hanger Clinic - 225 South Michigan Ave Suite B
  • Mississippi
    • Meridian, Mississippi, United States, 39301
      • Hanger Clinic - 1903 23rd Ave
    • Tupelo, Mississippi, United States, 38801
      • Hanger Clinic - 502 Council Circle
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Hanger Clinic - 3065 William Street, Suite 205
    • Kansas City, Missouri, United States, 64132
      • Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394
    • Saint Peters, Missouri, United States, 63376
      • Hanger Clinic - 150 St Peters Centre Blvd
  • Montana
    • Helena, Montana, United States, 59601
      • Hanger Clinic - 65 Medical Park Drive, Suite 3
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Hanger Clinic - 1001 S 70th St Ste 110
    • Omaha, Nebraska, United States, 68134
      • Hanger Clinic - 9109 Blondo Street
    • Omaha, Nebraska, United States, 68818
      • Hanger Clinic - 17500 Burke St, Suite 100
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Hanger Clinic - 7250 Peak Drive, STE 120
    • Reno, Nevada, United States, 89502
      • Hanger Clinic - 961 Matley Ln Ste 100
  • New Hampshire
    • Somersworth, New Hampshire, United States, 03878
      • Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste
  • New York
    • Rochester, New York, United States, 14618
      • Hanger Clinic - 1882 Winton Road South, Suite 6
    • Westbury, New York, United States, 11590
      • Hanger Clinic - 5502 Brush Hollow Rd.
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Hanger Clinic - 2219 E. 7th St.
    • Winston-Salem, North Carolina, United States, 27103
      • Hanger Clinic - 1399 Westgate Center Dr
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Hanger Clinic - One Elizabeth Place Suite 300
    • Fairfield, Ohio, United States, 45014
      • Hanger Clinic - 660 Wessel Drive
    • Mayfield Heights, Ohio, United States, 44124
      • Hanger Clinic - 6001 Landerhaven Dr Ste A
  • Pennsylvania
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Hanger Clinic - 423 Normal St.
    • Wyomissing, Pennsylvania, United States, 19610
      • Hanger Clinic - 40 Berkshire Ct STE 2
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Hanger Clinic - 305 E Greenville St
    • Columbia, South Carolina, United States, 29201
      • Hanger Clinic - 1739 Blanding St.
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Hanger Clinic - 779 W. Forest Ave
    • Johnson City, Tennessee, United States, 37601
      • Hanger Clinic - 502 Princeton Rd
    • Knoxville, Tennessee, United States, 37919
      • Hanger Clinic - 6300 Baum Dr
    • Maryville, Tennessee, United States, 37804
      • Hanger Clinic - 266 Cherokee Professional Park
    • Memphis, Tennessee, United States, 38104
      • Hanger Clinic - 7 North Bellevue Blvd
  • Texas
    • Conroe, Texas, United States, 77385
      • Hanger Clinic - 8000 State Highway 242, Suite 100
    • Dallas, Texas, United States, 75246
      • Hanger Clinic - 3910 Gaston Ave STE 150
    • Kerrville, Texas, United States, 78028
      • Hanger Clinic - 320 West Water St, Suite D
    • Round Rock, Texas, United States, 78665
      • Hanger Clinic - 4001 N Mays St. Ste 1200
    • San Antonio, Texas, United States, 78214
      • Hanger Clinic - 1139 S.E. Military Dr., Suite 111
    • Sulphur Springs, Texas, United States, 75482
      • Hanger Clinic - 1400 College St, Ste 7
    • Webster, Texas, United States, 77598
      • Hanger Clinic - 17490 Hwy 3 Unit 100A
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • Hanger Clinic - 2785 East 3300 South
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B
    • Portsmouth, Virginia, United States, 23703
      • Hanger Clinic - 5809 West Norfolk Road
  • Washington
    • Longview, Washington, United States, 98642
      • Hanger Clinic - 1516 Hudson Street, Suite 105
    • Renton, Washington, United States, 98057
      • Hanger Clinic - 401 SW 41st ST
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Hanger Clinic - 4407 MacCorkle Ave SE
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Hanger Clinic - 5027 Green Bay Rd, Suite 124
    • La Crosse, Wisconsin, United States, 54636
      • Hanger Clinic - 3440 Losey Blvd S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	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.	12 months
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	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).	12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	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 months
12-month fall count from bi-weekly fall journal	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.	12 months
Average daily step counts	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.	12 months
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	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.	3 years
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	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).	5 years
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	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.	5 years
10-meter Walk Test (10mWT)	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.	5 years
Timed Up and Go (TUG)	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.	5 years
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	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.	3 years
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	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 years
10-meter Walk Test (10mWT)	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.	3 years
Timed Up and Go (TUG)	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.	3 years

Collaborators and Investigators

• Sponsor: Otto Bock Healthcare Products GmbH
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2
• Other Study ID Numbers: OB113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No