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Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
NCT03718637 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03718637
The ClinicalTrials.gov registry entry for NCT03718637 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 171 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03718637 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03718637?
The interventions under investigation include: Smith & Nephew Bioinductive Implant (BIOLOGICAL), Lateral Epicondylectomy (PROCEDURE), Ultrasound Imaging (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03718637?
This trial is sponsored by Henry Ford Health System, which has 171 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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