Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy, Ultrasound Imaging.
- Who it may be relevant to
- Registry conditions: Tennis Elbow, Lateral Epicondylitis. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Overview
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.
Detailed description
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.
Interventions
- Biological Smith & Nephew Bioinductive Implant
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery. - Procedure Lateral Epicondylectomy
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options. - Radiation Ultrasound Imaging
An ultrasound will be performed on each patient both preoperatively and at 6 months.
Primary outcome measures
- PROMIS CAT Scores [Time frame: Preoperative to 1 year postoperative]
- Visual Analog Scale (VAS) for Pain [Time frame: Preoperative to 1 year postoperative]
- Range of Motion [Time frame: Preoperative to 1 year]
Eligibility criteria
Inclusion criteria
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Exclusion criteria
- Previous surgery on the currently-affected elbow.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Henry Ford Hospital — Detroit
Identifiers
NCT: NCT03718637 · 12495