Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Disqualifiers
Previous surgery on the currently-affected elbow.
Trial design
Design model
Parallel
Treatments tested in this trial
Smith & Nephew Bioinductive Implant
Biological/VaccineA bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
Lateral Epicondylectomy
Procedure/SurgeryThis procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
Ultrasound Imaging
RadiationAn ultrasound will be performed on each patient both preoperatively and at 6 months.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 2 interventions
Group B: ExperimentalExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
PROMIS CAT Scores
A short 5 minute survey asking questions about physical function, pain, and mental health
Time frame
Preoperative to 1 year postoperative2
Visual Analog Scale (VAS) for Pain
Traditional 1 to 10, subjective rating of pain the patient is experiencing
Time frame
Preoperative to 1 year postoperative3
Range of Motion
Standard range of motion values collected by the surgeon during preoperative and followup visits
Time frame
Preoperative to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry Ford Health System
Lead sponsor
Smith & Nephew, Inc.
Collaborator
Source ClinicalTrials.gov