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A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Primary and study completion dates: Dec 1, 2030 to Jul 1, 2034v14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary completion date: Aug 1, 2028 to Dec 1, 2030
    • Study completion date: Dec 1, 2028 to Dec 1, 2030
    • Study description expanded, about 15 words
    • Study title expanded, about 10 words
    v12
  5. Enrollment target: 100 to 220
    • Eligibility criteria expanded, about 98 words
    • Study sites revised (4)
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 5 to 4v10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 6 to 5v8
  4. 3 versions Re-verified since Jan 3, 2019, no change to tracked fieldsv5-v7
  5. Secondary endpoints: details revised at 1 of 3 entries
    • Study title expanded, about 2 words
    v4
  6. Primary endpoints: 2 to 1v3 Show 5 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 21 words
    • Site details revised at 6 of 6 sites
    • Study title shortened, about 3 words
  7. Secondary endpoints: details revised at 1 of 1 entryv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.
Trial Details
NCT Number NCT03610789
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Hip Replacement
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov