Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

NCT04784429 | Active Not Recruiting

• 1 other identifier: OB113
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 90

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

  12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

  12 months

• 12-month fall count from bi-weekly fall journal

  12 months

• Average daily step counts

  12 months

• Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

  3 years

Study Arms (2)

MPK

EXPERIMENTAL

Microprocessor controlled knee

Device: Kenevo or C-Leg 4

NMPK

ACTIVE COMPARATOR

Non-microprocessor controlled knee

Device: Non microprocessor controlled knee (NMPK)

Interventions

Kenevo or C-Leg 4 DEVICE

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.

MPK

Non microprocessor controlled knee (NMPK) DEVICE

NMPK consistent with current standards of care

NMPK

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead
• Hanger Clinic: Prosthetics & Orthotics: collaborator

Study Sites (90)

Hanger Clinic - 321 Westgate Pkwy

Dothan, Alabama, 36303, United States

Location

Hanger Clinic - 3501 S Mercy Road

Gilbert, Arizona, 85297, United States

Location

Hanger Clinic - 3816 N. 7th St.

Phoenix, Arizona, 85014, United States

Location

Hanger Clinic - 4045 E Bell Rd

Phoenix, Arizona, 85032, United States

Location

Hanger Clinic - 13925 Meeker Blvd, Suite 5

Sun City West, Arizona, 85375, United States

Location

Hanger Clinic - 4849 Lonetree Way, STE B

Antioch, California, 94531, United States

Location

Hanger Clinic - 1743 Creekside, Suite #110

Folsom, California, 95630, United States

Location

Hanger Clinic - California - 1248 32nd St

Sacramento, California, 95816, United States

Location

Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7

Torrance, California, 90505, United States

Location

Hanger Clinic - 820 S Akers St, Ste 230

Visalia, California, 93227, United States

Location

Hanger Clinic - 1215 Plumas Street, Suite 1000

Yuba City, California, 95991, United States

Location

Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place

Lakewood, Colorado, 80228, United States

Location

Hanger Clinic - 1119 Professional Park Drive

Brandon, Florida, 33511, United States

Location

Hanger Clinic - 1400 Mason Ave. Suite 103

Daytona Beach, Florida, 32117, United States

Location

Hanger Clinic - 12591 Creekside Lane

Fort Myers, Florida, 33919, United States

Location

Hanger Clinic - 221 W. Main Street

Inverness, Florida, 34450, United States

Location

Hanger Clinic - 308 East Oak Street

Kissimmee, Florida, 34744, United States

Location

Hanger Clinic - 6270 Naples Blvd, Bldg 1

Naples, Florida, 34109, United States

Location

Hanger Clinic - 824 Creighton Road

Pensacola, Florida, 32504, United States

Location

Hanger Clinic - 200 Southpark Blvd, Suite 209

Saint Augustine, Florida, 32086, United States

Location

Hanger Clinic - 215 First Street North, Suite 300A

Winter Haven, Florida, 33880, United States

Location

Hanger Clinic - 607 N. Jefferson Street

Albany, Georgia, 31707, United States

Location

Hanger Clinic - 1050 Buford Rd, Ste 106

Cumming, Georgia, 30041, United States

Location

Hanger Clinic - 778 Riverside Drive

Macon, Georgia, 31201, United States

Location

Hanger Clinic - 1215A Merchant Way

Statesboro, Georgia, 30458, United States

Location

Hanger Clinic - 11346 S Cicero Ave

Alsip, Illinois, 60803, United States

Location

Hanger Clinic - 2835 N Sheffield Ave, Ste 301

Chicago, Illinois, 60657, United States

Location

Hanger Clinic - 1551 Bond Street, Suite 111

Naperville, Illinois, 60563, United States

Location

Hanger Clinic - 401 Harrison Street

Oak Park, Illinois, 60304, United States

Location

Hanger Clinic - 355 W Carpenter St.

Springfield, Illinois, 62702, United States

Location

Hanger Clinic - 4821 Old National Road East, Suite A

Richmond, Indiana, 47374, United States

Location

Hanger Clinic - 4505 Utica Ridge Rd

Bettendorf, Iowa, 52722, United States

Location

Hanger Clinic - 866 5th Ave SE

Cedar Rapids, Iowa, 52403, United States

Location

Hanger Clinic - 330 Laurel St. #1300

Des Moines, Iowa, 50314, United States

Location

Hanger Clinic - 804 Kenyon Road

Fort Dodge, Iowa, 50521, United States

Location

Hanger Clinic - 645 East Crawford St

Salina, Kansas, 67401, United States

Location

Hanger Clinic - 410 N. Hillside, Suite 100

Wichita, Kansas, 67214, United States

Location

Hanger Clinic - 8522 Summa Ave

Baton Rouge, Louisiana, 70809, United States

Location

Hanger Clinic - 940 Kaliste Saloom

Lafayette, Louisiana, 70508, United States

Location

Hanger Clinic - 1010 Stillwater Ave, Ste 106

Bangor, Maine, 04401, United States

Location

Hanger Clinic - 959 Brighton Ave.

Portland, Maine, 04102, United States

Location

Hanger Clinic - 1001 Cromwell Bridge Rd, Suite 108

Towson, Maryland, 21286, United States

Location

Hanger Clinic - 100 Erdman Way, STE 100

Leominster, Massachusetts, 01453, United States

Location

Hanger Clinic - 100 Milk Street, Suite 120

Methuen, Massachusetts, 01844, United States

Location

Hanger Clinic - 1985 Main Street

Springfield, Massachusetts, 01103, United States

Location

Hanger Clinic - 225 South Michigan Ave Suite B

Big Rapids, Michigan, 48038, United States

Location

Hanger Clinic - 1903 23rd Ave

Meridian, Mississippi, 39301, United States

Location

Hanger Clinic - 502 Council Circle

Tupelo, Mississippi, 38801, United States

Location

Hanger Clinic - 3065 William Street, Suite 205

Cape Girardeau, Missouri, 63703, United States

Location

Hanger Clinic - 150 St Peters Centre Blvd

City of Saint Peters, Missouri, 63376, United States

Location

Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394

Kansas City, Missouri, 64132, United States

Location

Hanger Clinic - 65 Medical Park Drive, Suite 3

Helena, Montana, 59601, United States

Location

Hanger Clinic - 1001 S 70th St Ste 110

Lincoln, Nebraska, 68510, United States

Location

Hanger Clinic - 9109 Blondo Street

Omaha, Nebraska, 68134, United States

Location

Hanger Clinic - 17500 Burke St, Suite 100

Omaha, Nebraska, 68818, United States

Location

Hanger Clinic - 7250 Peak Drive, STE 120

Las Vegas, Nevada, 89128, United States

Location

Hanger Clinic - 961 Matley Ln Ste 100

Reno, Nevada, 89502, United States

Location

Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201

Somersworth, New Hampshire, 03878, United States

Location

Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste

Albuquerque, New Mexico, 87102, United States

Location

Hanger Clinic - 1882 Winton Road South, Suite 6

Rochester, New York, 14618, United States

Location

Hanger Clinic - 5502 Brush Hollow Rd.

Westbury, New York, 11590, United States

Location

Hanger Clinic - 2219 E. 7th St.

Charlotte, North Carolina, 28204, United States

Location

Hanger Clinic - 1399 Westgate Center Dr

Winston-Salem, North Carolina, 27103, United States

Location

Hanger Clinic - One Elizabeth Place Suite 300

Dayton, Ohio, 45417, United States

Location

Hanger Clinic - 660 Wessel Drive

Fairfield, Ohio, 45014, United States

Location

Hanger Clinic - 6001 Landerhaven Dr Ste A

Mayfield Heights, Ohio, 44124, United States

Location

Hanger Clinic - 423 Normal St.

East Stroudsburg, Pennsylvania, 18301, United States

Location

Hanger Clinic - 40 Berkshire Ct STE 2

Wyomissing, Pennsylvania, 19610, United States

Location

Hanger Clinic - 305 E Greenville St

Anderson, South Carolina, 29621, United States

Location

Hanger Clinic - 1739 Blanding St.

Columbia, South Carolina, 29201, United States

Location

Hanger Clinic - 779 W. Forest Ave

Jackson, Tennessee, 38301, United States

Location

Hanger Clinic - 502 Princeton Rd

Johnson City, Tennessee, 37601, United States

Location

Hanger Clinic - 6300 Baum Dr

Knoxville, Tennessee, 37919, United States

Location

Hanger Clinic - 266 Cherokee Professional Park

Maryville, Tennessee, 37804, United States

Location

Hanger Clinic - 7 North Bellevue Blvd

Memphis, Tennessee, 38104, United States

Location

Hanger Clinic - 8000 State Highway 242, Suite 100

Conroe, Texas, 77385, United States

Location

Hanger Clinic - 3910 Gaston Ave STE 150

Dallas, Texas, 75246, United States

Location

Hanger Clinic - 320 West Water St, Suite D

Kerrville, Texas, 78028, United States

Location

Hanger Clinic - 4001 N Mays St. Ste 1200

Round Rock, Texas, 78665, United States

Location

Hanger Clinic - 1139 S.E. Military Dr., Suite 111

San Antonio, Texas, 78214, United States

Location

Hanger Clinic - 1400 College St, Ste 7

Sulphur Springs, Texas, 75482, United States

Location

Hanger Clinic - 17490 Hwy 3 Unit 100A

Webster, Texas, 77598, United States

Location

Hanger Clinic - 2785 East 3300 South

Salt Lake City, Utah, 84109, United States

Location

Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B

Newport News, Virginia, 23606, United States

Location

Hanger Clinic - 5809 West Norfolk Road

Portsmouth, Virginia, 23703, United States

Location

Hanger Clinic - 1516 Hudson Street, Suite 105

Longview, Washington, 98642, United States

Location

Hanger Clinic - 401 SW 41st ST

Renton, Washington, 98057, United States

Location

Hanger Clinic - 4407 MacCorkle Ave SE

Charleston, West Virginia, 25304, United States

Location

Hanger Clinic - 5027 Green Bay Rd, Suite 124

Kenosha, Wisconsin, 53144, United States

Location

Hanger Clinic - 3440 Losey Blvd S

La Crosse, Wisconsin, 54636, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Andreas Kannenberg, MD, PhD

  Otto Bock Healthcare Products GmbH

  PRINCIPAL INVESTIGATOR

• Shane Wurdeman, PhD

  Hanger Clinic: Prosthetics & Orthotics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: June 11, 2021
• Primary Completion: June 29, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (90)