NCT Number: NCT03718637
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 4
Detroit, Michigan, 48202, United States
Location status: Recruiting
Elizabeth King, MD
SUB_INVESTIGATOR
Eric C Makhni, MD
SUB_INVESTIGATOR
Johnny Kasto, MD
CONTACT
Stephanie J Muh, MD
PRINCIPAL_INVESTIGATOR
Vasilios Moutzouros, MD
SUB_INVESTIGATOR
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
Other names: Bioinductive Patch
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
An ultrasound will be performed on each patient both preoperatively and at 6 months.
Time frame: Preoperative to 1 year postoperative
A short 5 minute survey asking questions about physical function, pain, and mental health
Time frame: Preoperative to 1 year postoperative
Traditional 1 to 10, subjective rating of pain the patient is experiencing
Time frame: Preoperative to 1 year
Standard range of motion values collected by the surgeon during preoperative and followup visits
Contact information is provided by the study sponsor or research team.
Henry Ford Health System
Other
Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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