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Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Study acronym: ASCENT K2
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 31, 2022 to Jun 29, 2023
    • Study sites: 87 to 90
    v6
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 107
    • Study sites: 121 to 87
    v5
  3. Study sites: 29 to 121v4
  4. Study sites: 1 to 29v3
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2021 to Jun 11, 2021
    • Eligibility criteria expanded, about 7 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04784429
Lead Sponsor Otto Bock Healthcare Products GmbH
Collaborators: Hanger Clinic: Prosthetics & Orthotics
Conditions
(from sponsor)		 Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee
Related terms Wounds and Injuries
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov