Your session is about to expire
← Back to Search
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 belowSelect...
My tennis elbow didn't improve with standard treatments like physical therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative to 1 year
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
2,099,842 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my affected elbow before.My tennis elbow didn't improve with standard treatments like physical therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Experimental
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger