Status:
ACTIVE_NOT_RECRUITING
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Lead Sponsor:
Otto Bock Healthcare Products GmbH
Collaborating Sponsors:
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Lower Limb Amputation Above Knee (Injury)
Congenital Amputation of Lower Limb
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 ...
Detailed Description
Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04784429
Start Date
June 11 2021
End Date
December 31 2026
Last Update
February 9 2024
Active Locations (90)
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1
Hanger Clinic - 321 Westgate Pkwy
Dothan, Alabama, United States, 36303
2
Hanger Clinic - 3501 S Mercy Road
Gilbert, Arizona, United States, 85297
3
Hanger Clinic - 3816 N. 7th St.
Phoenix, Arizona, United States, 85014
4
Hanger Clinic - 4045 E Bell Rd
Phoenix, Arizona, United States, 85032