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Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Study acronym: IMPACT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Aug 15, 2026 → Apr 15, 2027
See other at-risk trials from Smith & Nephew, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 15, 2026 to Apr 15, 2027 Show 6 more changesShow less
    • Lead sponsor: Smith & Nephew, Inc. to Smith & Nephew, Inc.
    • Study completion pushed from Jun 30, 2028 to Feb 28, 2029
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 16 of 25 entries
    • Study description revised
    • Site details revised at 2 of 20 sites
  2. Site details revised at 2 of 20 sitesv24
  3. 2 versions Re-verified since Dec 2, 2025, no change to tracked fieldsv22-v23
  4. Site details revised at 3 of 20 sitesv21
  5. Enrollment target: 156 to 234
    • Primary completion date: Sep 30, 2025 to Aug 15, 2026
    • Study completion date: Jun 30, 2027 to Jun 30, 2028
    • Site details revised at 9 of 20 sites
    v20
Show 18 earlier versionsHide 18 earlier versions
  1. Site details revised at 3 of 20 sitesv19
  2. Study sites: 19 to 20v18
  3. Primary completion date: Mar 31, 2024 to Sep 30, 2025
    • Study completion date: Dec 31, 2025 to Jun 30, 2027
    • Site details revised at 2 of 19 sites
    v17
  4. Site contacts updated at 1 of 19 sitesv16
  5. Site details revised at 1 of 19 sitesv15
  6. Site details revised at 1 of 19 sitesv14
  7. Site details revised at 4 of 19 sitesv13
  8. Eligibility criteria expanded, about 12 wordsv12
  9. Re-verified, no change to tracked fieldsv11
  10. Site details revised at 1 of 19 sitesv10
  11. Site details revised at 1 of 19 sitesv9
  12. Site details revised at 3 of 19 sitesv8
  13. Primary completion date: Aug 31, 2023 to Mar 31, 2024
    • Study completion date: May 31, 2025 to Dec 31, 2025
    • Study sites revised (19)
    v7
  14. Site details revised at 1 of 19 sitesv6
  15. Study sites: 15 to 19v5
  16. Study sites: 13 to 15v4
  17. Site details revised at 1 of 13 sitesv3
  18. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jul 15, 2022 to Aug 30, 2022
    • Study sites: 8 to 13
    • Secondary endpoints: details revised at 5 of 25 entries
    • Eligibility criteria expanded, about 1 word
  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 purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
Trial Details
NCT Number NCT05444465
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Rotator Cuff Injuries
Related terms Rotator Cuff Injuries
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov