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NCT03718637 · ClinicalTrials.gov registry record · Phase 4
Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
A Phase 4 study of Lateral Epicondylitis and Tennis Elbow, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03718637: Recruiting Phase 4 study of Lateral Epicondylitis and Tennis Elbow, sponsored by Henry Ford Health System.
NCT03718637 is a Phase 4 study of Lateral Epicondylitis and Tennis Elbow that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 40 participants, below the 122-participant average among 7 other Lateral Epicondylitis trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03718637, a Phase 4 study of Lateral Epicondylitis and Tennis Elbow, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A short 5 minute survey asking questions about physical function, pain, and mental health
Conditions Studied
Interventions
- BIOLOGICAL Smith & Nephew Bioinductive Implant
- PROCEDURE Lateral Epicondylectomy
- RADIATION Ultrasound Imaging
Study Locations (1)
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2027-01-17 |
| Phase | Phase 4 |
What NCT03718637 shows while recruiting
NCT03718637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 122-participant average among 7 other Lateral Epicondylitis trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Lateral Epicondylitis appearing as the primary indexed condition, and to 3 interventions - of which Smith & Nephew Bioinductive Implant is the first listed.
NCT03718637 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03718637 about?
NCT03718637 is a clinical study titled "Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)". 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 inve...
What is the current status of trial NCT03718637?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-04-17. Estimated completion is 2027-01-17.
What conditions does trial NCT03718637 study?
This clinical trial studies the following conditions: Lateral Epicondylitis, Tennis Elbow.
What interventions are being tested in trial NCT03718637?
The interventions under investigation include: Smith & Nephew Bioinductive Implant (BIOLOGICAL), Lateral Epicondylectomy (PROCEDURE), Ultrasound Imaging (RADIATION).
Who is sponsoring clinical trial NCT03718637?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03718637 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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