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Clinical Trials in the USA / NCT04784429
Active, not recruiting Not applicable

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

NCT04784429 · tracked via the Priya Life Science USA tracker
Sponsor
Otto Bock Healthcare Products GmbH
Phase
Not applicable
Started
2021-06-11
Last updated
2024-02-09

Condition(s) studied

Lower Limb Amputation Above Knee (Injury)Congenital Amputation of Lower LimbLower Limb Amputation Knee

Investigational drug(s) / intervention(s)

Kenevo or C-Leg 4Non microprocessor controlled knee (NMPK)

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

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Fear of Falling Avoidance Behavior Questionnaire (FFABQ) — 12 months
    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.
  • 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.

Trial sites (90)

FacilityCityRegionStatus
Hanger Clinic - 321 Westgate Pkwy Dothan Alabama
Hanger Clinic - 3501 S Mercy Road Gilbert Arizona
Hanger Clinic - 3816 N. 7th St. Phoenix Arizona
Hanger Clinic - 4045 E Bell Rd Phoenix Arizona
Hanger Clinic - 13925 Meeker Blvd, Suite 5 Sun City West Arizona
Hanger Clinic - 4849 Lonetree Way, STE B Antioch California
Hanger Clinic - 1743 Creekside, Suite #110 Folsom California
Hanger Clinic - California - 1248 32nd St Sacramento California
Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7 Torrance California
Hanger Clinic - 820 S Akers St, Ste 230 Visalia California
Hanger Clinic - 1215 Plumas Street, Suite 1000 Yuba City California
Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place Lakewood Colorado
Hanger Clinic - 1119 Professional Park Drive Brandon Florida
Hanger Clinic - 1400 Mason Ave. Suite 103 Daytona Beach Florida
Hanger Clinic - 12591 Creekside Lane Fort Myers Florida
Hanger Clinic - 221 W. Main Street Inverness Florida
Hanger Clinic - 308 East Oak Street Kissimmee Florida
Hanger Clinic - 6270 Naples Blvd, Bldg 1 Naples Florida
Hanger Clinic - 824 Creighton Road Pensacola Florida
Hanger Clinic - 200 Southpark Blvd, Suite 209 Saint Augustine Florida
Hanger Clinic - 215 First Street North, Suite 300A Winter Haven Florida
Hanger Clinic - 607 N. Jefferson Street Albany Georgia
Hanger Clinic - 1050 Buford Rd, Ste 106 Cumming Georgia
Hanger Clinic - 778 Riverside Drive Macon Georgia
Hanger Clinic - 1215A Merchant Way Statesboro Georgia
Hanger Clinic - 11346 S Cicero Ave Alsip Illinois
Hanger Clinic - 2835 N Sheffield Ave, Ste 301 Chicago Illinois
Hanger Clinic - 1551 Bond Street, Suite 111 Naperville Illinois
Hanger Clinic - 401 Harrison Street Oak Park Illinois
Hanger Clinic - 355 W Carpenter St. Springfield Illinois
Hanger Clinic - 4821 Old National Road East, Suite A Richmond Indiana
Hanger Clinic - 4505 Utica Ridge Rd Bettendorf Iowa
Hanger Clinic - 866 5th Ave SE Cedar Rapids Iowa
Hanger Clinic - 330 Laurel St. #1300 Des Moines Iowa
Hanger Clinic - 804 Kenyon Road Fort Dodge Iowa
Hanger Clinic - 645 East Crawford St Salina Kansas
Hanger Clinic - 410 N. Hillside, Suite 100 Wichita Kansas
Hanger Clinic - 8522 Summa Ave Baton Rouge Louisiana
Hanger Clinic - 940 Kaliste Saloom Lafayette Louisiana
Hanger Clinic - 1010 Stillwater Ave, Ste 106 Bangor Maine

+ 50 more sites — see the full list on the official registry below.

More Otto Bock Healthcare Products GmbH trials in the USA

Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis Starting soon
C-Brace Prospective Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04784429 on ClinicalTrials.gov ↗ ← All trials in the USA