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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 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.

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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.

Conditions Studied

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

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

FieldValue
Enrollment Target 107 participants
Start Date 2021-06-11
Est. Completion 2026-12-31
Phase NA

Sponsor

Otto Bock Healthcare Products

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04784429

The ClinicalTrials.gov registry entry for NCT04784429 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 73-participant average among 6 other Lower Limb Amputation Above Knee (Injury) trials with a reported enrollment target (47% higher). The listed sponsor is Otto Bock Healthcare Products, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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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