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Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

NCT04784429 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-02-09

No results posted yet for this 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

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

Interventions

DEVICE

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.

DEVICE

Non microprocessor controlled knee (NMPK)

NMPK consistent with current standards of care

Sponsors & Collaborators

  • Hanger Clinic: Prosthetics & Orthotics

    collaborator OTHER

  • Otto Bock Healthcare Products GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Kannenberg, MD, PhD · Otto Bock Healthcare Products GmbH

  • Shane Wurdeman, PhD · Hanger Clinic: Prosthetics & Orthotics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2023-06-29
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784429 on ClinicalTrials.gov