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Bioinductive Implant

Bioinductive Implant for Tennis Elbow

Phase 4
Recruiting
Led By Stephanie J Muh, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative to 1 year
Awards & highlights

Study Summary

This trial is testing a new patch that may help regrow tendon tissue for people with tennis elbow who haven't responded to other treatments. Half the patients will get the patch during surgery, and the other half will just have surgery. The investigators will compare how well the patch works by looking at things like ultrasound studies and other measures.

Who is the study for?
This trial is for individuals with tennis elbow that hasn't improved after physical therapy, lifestyle changes, and anti-inflammatory treatments. It's not open to those who've had previous surgery on the affected elbow.Check my eligibility
What is being tested?
The study compares traditional surgery for tennis elbow against the same surgery plus a new FDA-approved bioinductive patch designed to promote tendon healing. Participants will be randomly assigned to one of these two groups.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks like infection or pain at the incision site, as well as specific reactions related to the bioinductive implant such as inflammation or immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tennis elbow didn't improve with standard treatments like physical therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PROMIS CAT Scores
Range of Motion
Visual Analog Scale (VAS) for Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment3 Interventions
Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Group II: ControlActive Control2 Interventions
Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~730

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Industry Sponsor
165 Previous Clinical Trials
22,441 Total Patients Enrolled
2 Trials studying Tennis Elbow
154 Patients Enrolled for Tennis Elbow
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,959 Total Patients Enrolled
1 Trials studying Tennis Elbow
80 Patients Enrolled for Tennis Elbow
Stephanie J Muh, MDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Smith & Nephew Bioinductive Implant (Bioinductive Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03718637 — Phase 4
Tennis Elbow Research Study Groups: Control, Experimental
Tennis Elbow Clinical Trial 2023: Smith & Nephew Bioinductive Implant Highlights & Side Effects. Trial Name: NCT03718637 — Phase 4
Smith & Nephew Bioinductive Implant (Bioinductive Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718637 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA recognize Lateral Epicondylectomy as a viable treatment option?

"The known safety profile of Lateral Epicondylectomy scores highly with a rating of 3 on our scale, as this is part of an approved Phase 4 clinical trial."

Answered by AI

Are there still vacancies to participate in this scientific experiment?

"Affirmative. Clinicaltrials.gov shows that this medical trial, first published on April 17th 2019, is currently seeking volunteers to take part in the study. Forty people must be recruited from a single site."

Answered by AI

How many persons have signed up to participate in this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this trial is still ongoing since it was initially posted in April 2019 and last updated in February 2022. The study requires 40 individuals from one single medical site."

Answered by AI
~7 spots leftby May 2025