Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
- Conditions
- Lower Limb Amputation Above Knee (Injury)Lower Limb Amputation KneeCongenital Amputation of Lower Limb
- Interventions
- Device: Kenevo or C-Leg 4Device: Non microprocessor controlled knee (NMPK)
- Registration Number
- NCT04784429
- Lead Sponsor
- Otto Bock Healthcare Products GmbH
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 107
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MPK Kenevo or C-Leg 4 Microprocessor controlled knee NMPK Non microprocessor controlled knee (NMPK) Non-microprocessor controlled knee
- Primary Outcome Measures
Name Time Method Fear of Falling Avoidance Behavior Questionnaire (FFABQ) 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
Name Time Method Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 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.
Average daily step counts 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.
12-month fall count from bi-weekly fall journal 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.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ) 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.
10-meter Walk Test (10mWT) 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) 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.
Trial Locations
- Locations (90)
Hanger Clinic - 1215 Plumas Street, Suite 1000
🇺🇸Yuba City, California, United States
Hanger Clinic - 7250 Peak Drive, STE 120
🇺🇸Las Vegas, Nevada, United States
Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste
🇺🇸Albuquerque, New Mexico, United States
Hanger Clinic - One Elizabeth Place Suite 300
🇺🇸Dayton, Ohio, United States
Hanger Clinic - 13925 Meeker Blvd, Suite 5
🇺🇸Sun City West, Arizona, United States
Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7
🇺🇸Torrance, California, United States
Hanger Clinic - 1119 Professional Park Drive
🇺🇸Brandon, Florida, United States
Hanger Clinic - 11346 S Cicero Ave
🇺🇸Alsip, Illinois, United States
Hanger Clinic - 820 S Akers St, Ste 230
🇺🇸Visalia, California, United States
Hanger Clinic - 1400 Mason Ave. Suite 103
🇺🇸Daytona Beach, Florida, United States
Hanger Clinic - 321 Westgate Pkwy
🇺🇸Dothan, Alabama, United States
Hanger Clinic - 12591 Creekside Lane
🇺🇸Fort Myers, Florida, United States
Hanger Clinic - 221 W. Main Street
🇺🇸Inverness, Florida, United States
Hanger Clinic - 4821 Old National Road East, Suite A
🇺🇸Richmond, Indiana, United States
Hanger Clinic - 215 First Street North, Suite 300A
🇺🇸Winter Haven, Florida, United States
Hanger Clinic - 410 N. Hillside, Suite 100
🇺🇸Wichita, Kansas, United States
Hanger Clinic - 2835 N Sheffield Ave, Ste 301
🇺🇸Chicago, Illinois, United States
Hanger Clinic - 355 W Carpenter St.
🇺🇸Springfield, Illinois, United States
Hanger Clinic - 401 Harrison Street
🇺🇸Oak Park, Illinois, United States
Hanger Clinic - 645 East Crawford St
🇺🇸Salina, Kansas, United States
Hanger Clinic - 100 Erdman Way, STE 100
🇺🇸Leominster, Massachusetts, United States
Hanger Clinic - 4505 Utica Ridge Rd
🇺🇸Bettendorf, Iowa, United States
Hanger Clinic - 940 Kaliste Saloom
🇺🇸Lafayette, Louisiana, United States
Hanger Clinic - 1010 Stillwater Ave, Ste 106
🇺🇸Bangor, Maine, United States
Hanger Clinic - 959 Brighton Ave.
🇺🇸Portland, Maine, United States
Hanger Clinic - 1001 Cromwell Bridge Rd, Suite 108
🇺🇸Towson, Maryland, United States
Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394
🇺🇸Kansas City, Missouri, United States
Hanger Clinic - 1001 S 70th St Ste 110
🇺🇸Lincoln, Nebraska, United States
Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201
🇺🇸Somersworth, New Hampshire, United States
Hanger Clinic - 961 Matley Ln Ste 100
🇺🇸Reno, Nevada, United States
Hanger Clinic - 660 Wessel Drive
🇺🇸Fairfield, Ohio, United States
Hanger Clinic - 1882 Winton Road South, Suite 6
🇺🇸Rochester, New York, United States
Hanger Clinic - 65 Medical Park Drive, Suite 3
🇺🇸Helena, Montana, United States
Hanger Clinic - 320 West Water St, Suite D
🇺🇸Kerrville, Texas, United States
Hanger Clinic - 6001 Landerhaven Dr Ste A
🇺🇸Mayfield Heights, Ohio, United States
Hanger Clinic - 3910 Gaston Ave STE 150
🇺🇸Dallas, Texas, United States
Hanger Clinic - 266 Cherokee Professional Park
🇺🇸Maryville, Tennessee, United States
Hanger Clinic - 5027 Green Bay Rd, Suite 124
🇺🇸Kenosha, Wisconsin, United States
Hanger Clinic - 3440 Losey Blvd S
🇺🇸La Crosse, Wisconsin, United States
Hanger Clinic - 3816 N. 7th St.
🇺🇸Phoenix, Arizona, United States
Hanger Clinic - 4045 E Bell Rd
🇺🇸Phoenix, Arizona, United States
Hanger Clinic - 423 Normal St.
🇺🇸East Stroudsburg, Pennsylvania, United States
Hanger Clinic - 9109 Blondo Street
🇺🇸Omaha, Nebraska, United States
Hanger Clinic - 17500 Burke St, Suite 100
🇺🇸Omaha, Nebraska, United States
Hanger Clinic - 1139 S.E. Military Dr., Suite 111
🇺🇸San Antonio, Texas, United States
Hanger Clinic - 2785 East 3300 South
🇺🇸Salt Lake City, Utah, United States
Hanger Clinic - 200 Southpark Blvd, Suite 209
🇺🇸Saint Augustine, Florida, United States
Hanger Clinic - 779 W. Forest Ave
🇺🇸Jackson, Tennessee, United States
Hanger Clinic - 308 East Oak Street
🇺🇸Kissimmee, Florida, United States
Hanger Clinic - 1215A Merchant Way
🇺🇸Statesboro, Georgia, United States
Hanger Clinic - California - 1248 32nd St
🇺🇸Sacramento, California, United States
Hanger Clinic - 1743 Creekside, Suite #110
🇺🇸Folsom, California, United States
Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place
🇺🇸Lakewood, Colorado, United States
Hanger Clinic - 1551 Bond Street, Suite 111
🇺🇸Naperville, Illinois, United States
Hanger Clinic - 804 Kenyon Road
🇺🇸Fort Dodge, Iowa, United States
Hanger Clinic - 866 5th Ave SE
🇺🇸Cedar Rapids, Iowa, United States
Hanger Clinic - 8522 Summa Ave
🇺🇸Baton Rouge, Louisiana, United States
Hanger Clinic - 330 Laurel St. #1300
🇺🇸Des Moines, Iowa, United States
Hanger Clinic - 225 South Michigan Ave Suite B
🇺🇸Big Rapids, Michigan, United States
Hanger Clinic - 1985 Main Street
🇺🇸Springfield, Massachusetts, United States
Hanger Clinic - 3065 William Street, Suite 205
🇺🇸Cape Girardeau, Missouri, United States
Hanger Clinic - 1903 23rd Ave
🇺🇸Meridian, Mississippi, United States
Hanger Clinic - 502 Council Circle
🇺🇸Tupelo, Mississippi, United States
Hanger Clinic - 150 St Peters Centre Blvd
🇺🇸Saint Peters, Missouri, United States
Hanger Clinic - 1399 Westgate Center Dr
🇺🇸Winston-Salem, North Carolina, United States
Hanger Clinic - 5502 Brush Hollow Rd.
🇺🇸Westbury, New York, United States
Hanger Clinic - 2219 E. 7th St.
🇺🇸Charlotte, North Carolina, United States
Hanger Clinic - 1739 Blanding St.
🇺🇸Columbia, South Carolina, United States
Hanger Clinic - 40 Berkshire Ct STE 2
🇺🇸Wyomissing, Pennsylvania, United States
Hanger Clinic - 305 E Greenville St
🇺🇸Anderson, South Carolina, United States
Hanger Clinic - 502 Princeton Rd
🇺🇸Johnson City, Tennessee, United States
Hanger Clinic - 7 North Bellevue Blvd
🇺🇸Memphis, Tennessee, United States
Hanger Clinic - 8000 State Highway 242, Suite 100
🇺🇸Conroe, Texas, United States
Hanger Clinic - 4001 N Mays St. Ste 1200
🇺🇸Round Rock, Texas, United States
Hanger Clinic - 1400 College St, Ste 7
🇺🇸Sulphur Springs, Texas, United States
Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B
🇺🇸Newport News, Virginia, United States
Hanger Clinic - 17490 Hwy 3 Unit 100A
🇺🇸Webster, Texas, United States
Hanger Clinic - 5809 West Norfolk Road
🇺🇸Portsmouth, Virginia, United States
Hanger Clinic - 1516 Hudson Street, Suite 105
🇺🇸Longview, Washington, United States
Hanger Clinic - 4407 MacCorkle Ave SE
🇺🇸Charleston, West Virginia, United States
Hanger Clinic - 401 SW 41st ST
🇺🇸Renton, Washington, United States
Hanger Clinic - 6300 Baum Dr
🇺🇸Knoxville, Tennessee, United States
Hanger Clinic - 3501 S Mercy Road
🇺🇸Gilbert, Arizona, United States
Hanger Clinic - 778 Riverside Drive
🇺🇸Macon, Georgia, United States
Hanger Clinic - 1050 Buford Rd, Ste 106
🇺🇸Cumming, Georgia, United States
Hanger Clinic - 824 Creighton Road
🇺🇸Pensacola, Florida, United States
Hanger Clinic - 100 Milk Street, Suite 120
🇺🇸Methuen, Massachusetts, United States
Hanger Clinic - 6270 Naples Blvd, Bldg 1
🇺🇸Naples, Florida, United States
Hanger Clinic - 607 N. Jefferson Street
🇺🇸Albany, Georgia, United States
Hanger Clinic - 4849 Lonetree Way, STE B
🇺🇸Antioch, California, United States