Clinical trial NCT04784429: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Official title: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Limb Amputation Above Knee (Injury)
Congenital Amputation of Lower Limb
Lower Limb Amputation Knee
Keywords: Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
Collaborators: name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2021-03-05
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

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