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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively. |
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| Experimental | Experimental | Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smith & Nephew Bioinductive Implant | Biological | A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| PROMIS CAT Scores | A short 5 minute survey asking questions about physical function, pain, and mental health | Preoperative to 1 year postoperative |
| Visual Analog Scale (VAS) for Pain | Traditional 1 to 10, subjective rating of pain the patient is experiencing | Preoperative to 1 year postoperative |
| Range of Motion | Standard range of motion values collected by the surgeon during preoperative and followup visits | Preoperative to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johnny Kasto, MD | Contact | 3132448078 | jkasto1@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie J Muh, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
No IPD will be shared with other researchers.
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.
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The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
| Lateral Epicondylectomy | Procedure | This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options. |
|
| Ultrasound Imaging | Radiation | An ultrasound will be performed on each patient both preoperatively and at 6 months. |
|
| D001134 |
| Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D055585 |
| Physical Phenomena |