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Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 12, 2025 (before its estimated May 17, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: May 17, 2025 to May 17, 2026
    • Study completion date: May 17, 2025 to Jan 17, 2027
    • Site contact updated
    v6
  2. Primary and study completion dates: Mar 30, 2024 to May 17, 2025v5
  3. Primary and study completion dates: Mar 30, 2023 to Mar 30, 2024
    • Site contact updated
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Mar 30, 2020 to Mar 30, 2023
    • Site details revised
    v3
  5. Start date: Nov 2018 to Apr 17, 2019
    • Primary completion date: Nov 30, 2019 to Mar 30, 2020
    • Study completion date: Nov 30, 2020 to Mar 30, 2020
    • Study description expanded, about 107 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.
Trial Details
NCT Number NCT03718637
Lead Sponsor Henry Ford Health System
Collaborators: Smith & Nephew, Inc.
Conditions
(from sponsor)		 Tennis Elbow, Lateral Epicondylitis
Related terms Tendinopathy, Tennis Elbow
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov