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NCT04784429 · ClinicalTrials.gov registry record · NA
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
A NA study of Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee, sponsored by Otto Bock Healthcare Products.
- Active
- Registry status
- NA
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT04784429: Active NA study of Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee, sponsored by Otto Bock Healthcare Products.
NCT04784429 is a NA study of Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee that is active but no longer recruiting, run by Otto Bock Healthcare Products. The registered enrollment target is 107 participants, above the 73-participant average among 6 other Lower Limb Amputation Above Knee (Injury) trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04784429, a NA study of Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee, is active but no longer recruiting, sponsored by Otto Bock Healthcare Products.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Kenevo or C-Leg 4
- DEVICE Non microprocessor controlled knee (NMPK)
Study Locations (20)
Florida
- Hanger Clinic - 1119 Professional Park Drive - Brandon
- Hanger Clinic - 1400 Mason Ave. Suite 103 - Daytona Beach
- Hanger Clinic - 12591 Creekside Lane - Fort Myers
- Hanger Clinic - 221 W. Main Street - Inverness
- Hanger Clinic - 308 East Oak Street - Kissimmee
- Hanger Clinic - 6270 Naples Blvd, Bldg 1 - Naples
- Hanger Clinic - 824 Creighton Road - Pensacola
- Hanger Clinic - 200 Southpark Blvd, Suite 209 - Saint Augustine
California
- Hanger Clinic - 4849 Lonetree Way, STE B - Antioch
- Hanger Clinic - 1743 Creekside, Suite #110 - Folsom
- Hanger Clinic - California - 1248 32nd St - Sacramento
- Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7 - Torrance
- Hanger Clinic - 820 S Akers St, Ste 230 - Visalia
- Hanger Clinic - 1215 Plumas Street, Suite 1000 - Yuba City
Arizona
- Hanger Clinic - 3501 S Mercy Road - Gilbert
- Hanger Clinic - 3816 N. 7th St. - Phoenix
- Hanger Clinic - 4045 E Bell Rd - Phoenix
- Hanger Clinic - 13925 Meeker Blvd, Suite 5 - Sun City West
Alabama
- Hanger Clinic - 321 Westgate Pkwy - Dothan
Colorado
- Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What the registry record for NCT04784429 still lists
NCT04784429 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 6 other Lower Limb Amputation Above Knee (Injury) trials with a reported enrollment target (47% higher).
The record links to 3 conditions, with Lower Limb Amputation Above Knee (Injury) appearing as the primary indexed condition, and to 2 interventions - of which Kenevo or C-Leg 4 is the first listed.
NCT04784429 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04784429 about?
NCT04784429 is a clinical study titled "Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population". 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.
What is the current status of trial NCT04784429?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 107 participants. The study started on 2021-06-11. Estimated completion is 2026-12-31.
What conditions does trial NCT04784429 study?
This clinical trial studies the following conditions: Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee, Congenital Amputation of Lower Limb.
What interventions are being tested in trial NCT04784429?
The interventions under investigation include: Kenevo or C-Leg 4 (DEVICE), Non microprocessor controlled knee (NMPK) (DEVICE).
Who is sponsoring clinical trial NCT04784429?
This trial is sponsored by Otto Bock Healthcare Products, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04784429 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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