Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
NCT ID: NCT04784429
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
107 participants
INTERVENTIONAL
2021-06-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MPK
Microprocessor controlled knee
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.
NMPK
Non-microprocessor controlled knee
Non microprocessor controlled knee (NMPK)
NMPK consistent with current standards of care
Interventions
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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.
Non microprocessor controlled knee (NMPK)
NMPK consistent with current standards of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Hanger Clinic: Prosthetics & Orthotics
OTHER
Otto Bock Healthcare Products GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Kannenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Otto Bock Healthcare Products GmbH
Shane Wurdeman, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanger Clinic: Prosthetics & Orthotics
Locations
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Hanger Clinic - 321 Westgate Pkwy
Dothan, Alabama, United States
Hanger Clinic - 3501 S Mercy Road
Gilbert, Arizona, United States
Hanger Clinic - 3816 N. 7th St.
Phoenix, Arizona, United States
Hanger Clinic - 4045 E Bell Rd
Phoenix, Arizona, United States
Hanger Clinic - 13925 Meeker Blvd, Suite 5
Sun City West, Arizona, United States
Hanger Clinic - 4849 Lonetree Way, STE B
Antioch, California, United States
Hanger Clinic - 1743 Creekside, Suite #110
Folsom, California, United States
Hanger Clinic - California - 1248 32nd St
Sacramento, California, United States
Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7
Torrance, California, United States
Hanger Clinic - 820 S Akers St, Ste 230
Visalia, California, United States
Hanger Clinic - 1215 Plumas Street, Suite 1000
Yuba City, California, United States
Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place
Lakewood, Colorado, United States
Hanger Clinic - 1119 Professional Park Drive
Brandon, Florida, United States
Hanger Clinic - 1400 Mason Ave. Suite 103
Daytona Beach, Florida, United States
Hanger Clinic - 12591 Creekside Lane
Fort Myers, Florida, United States
Hanger Clinic - 221 W. Main Street
Inverness, Florida, United States
Hanger Clinic - 308 East Oak Street
Kissimmee, Florida, United States
Hanger Clinic - 6270 Naples Blvd, Bldg 1
Naples, Florida, United States
Hanger Clinic - 824 Creighton Road
Pensacola, Florida, United States
Hanger Clinic - 200 Southpark Blvd, Suite 209
Saint Augustine, Florida, United States
Hanger Clinic - 215 First Street North, Suite 300A
Winter Haven, Florida, United States
Hanger Clinic - 607 N. Jefferson Street
Albany, Georgia, United States
Hanger Clinic - 1050 Buford Rd, Ste 106
Cumming, Georgia, United States
Hanger Clinic - 778 Riverside Drive
Macon, Georgia, United States
Hanger Clinic - 1215A Merchant Way
Statesboro, Georgia, United States
Hanger Clinic - 11346 S Cicero Ave
Alsip, Illinois, United States
Hanger Clinic - 2835 N Sheffield Ave, Ste 301
Chicago, Illinois, United States
Hanger Clinic - 1551 Bond Street, Suite 111
Naperville, Illinois, United States
Hanger Clinic - 401 Harrison Street
Oak Park, Illinois, United States
Hanger Clinic - 355 W Carpenter St.
Springfield, Illinois, United States
Hanger Clinic - 4821 Old National Road East, Suite A
Richmond, Indiana, United States
Hanger Clinic - 4505 Utica Ridge Rd
Bettendorf, Iowa, United States
Hanger Clinic - 866 5th Ave SE
Cedar Rapids, Iowa, United States
Hanger Clinic - 330 Laurel St. #1300
Des Moines, Iowa, United States
Hanger Clinic - 804 Kenyon Road
Fort Dodge, Iowa, United States
Hanger Clinic - 645 East Crawford St
Salina, Kansas, United States
Hanger Clinic - 410 N. Hillside, Suite 100
Wichita, Kansas, United States
Hanger Clinic - 8522 Summa Ave
Baton Rouge, Louisiana, 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 - 100 Erdman Way, STE 100
Leominster, Massachusetts, United States
Hanger Clinic - 100 Milk Street, Suite 120
Methuen, Massachusetts, United States
Hanger Clinic - 1985 Main Street
Springfield, Massachusetts, United States
Hanger Clinic - 225 South Michigan Ave Suite B
Big Rapids, Michigan, United States
Hanger Clinic - 1903 23rd Ave
Meridian, Mississippi, United States
Hanger Clinic - 502 Council Circle
Tupelo, Mississippi, United States
Hanger Clinic - 3065 William Street, Suite 205
Cape Girardeau, Missouri, United States
Hanger Clinic - 150 St Peters Centre Blvd
City of Saint Peters, Missouri, United States
Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394
Kansas City, Missouri, United States
Hanger Clinic - 65 Medical Park Drive, Suite 3
Helena, Montana, United States
Hanger Clinic - 1001 S 70th St Ste 110
Lincoln, Nebraska, United States
Hanger Clinic - 9109 Blondo Street
Omaha, Nebraska, United States
Hanger Clinic - 17500 Burke St, Suite 100
Omaha, Nebraska, United States
Hanger Clinic - 7250 Peak Drive, STE 120
Las Vegas, Nevada, United States
Hanger Clinic - 961 Matley Ln Ste 100
Reno, Nevada, United States
Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201
Somersworth, New Hampshire, United States
Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste
Albuquerque, New Mexico, United States
Hanger Clinic - 1882 Winton Road South, Suite 6
Rochester, New York, 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 - 1399 Westgate Center Dr
Winston-Salem, North Carolina, United States
Hanger Clinic - One Elizabeth Place Suite 300
Dayton, Ohio, United States
Hanger Clinic - 660 Wessel Drive
Fairfield, Ohio, United States
Hanger Clinic - 6001 Landerhaven Dr Ste A
Mayfield Heights, Ohio, United States
Hanger Clinic - 423 Normal St.
East Stroudsburg, Pennsylvania, 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 - 1739 Blanding St.
Columbia, South Carolina, United States
Hanger Clinic - 779 W. Forest Ave
Jackson, Tennessee, United States
Hanger Clinic - 502 Princeton Rd
Johnson City, Tennessee, United States
Hanger Clinic - 6300 Baum Dr
Knoxville, Tennessee, United States
Hanger Clinic - 266 Cherokee Professional Park
Maryville, 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 - 3910 Gaston Ave STE 150
Dallas, Texas, United States
Hanger Clinic - 320 West Water St, Suite D
Kerrville, Texas, United States
Hanger Clinic - 4001 N Mays St. Ste 1200
Round Rock, Texas, United States
Hanger Clinic - 1139 S.E. Military Dr., Suite 111
San Antonio, Texas, United States
Hanger Clinic - 1400 College St, Ste 7
Sulphur Springs, Texas, United States
Hanger Clinic - 17490 Hwy 3 Unit 100A
Webster, Texas, United States
Hanger Clinic - 2785 East 3300 South
Salt Lake City, Utah, United States
Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B
Newport News, Virginia, 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 - 401 SW 41st ST
Renton, Washington, United States
Hanger Clinic - 4407 MacCorkle Ave SE
Charleston, West Virginia, 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
Countries
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Other Identifiers
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OB113
Identifier Type: -
Identifier Source: org_study_id
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