Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Running, not enrolling · Not applicable

Conditions studied: Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee

In brief

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.

Key facts

Study ID

NCT04784429

Run by

Otto Bock Healthcare Products GmbH

People needed

107

Starts

2021-06-11

Expected to finish

2026-12-31

Last updated by the study team

2024-02-09

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 - 321 Westgate Pkwy — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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