Efficacy of Connective Tissue Allograft Versus Steroid Injections in Treatment of Lateral Epicondylitis

IHTSC CTM Project HC22-1

In this study, the objective is to evaluate the effectiveness of a single application of human Connective Tissue Allograft (CTA) as a treatment of LET. CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. Drug/Device Handling: If the research involves drugs or device, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators.

2023-01-26

2025-12-31

2025-12-31

Early phase I

54

Inclusion Criteria: 1. Males or females age 18 or older 2. Patients presenting with symptomatic lateral epicondylitis for at least 6 weeks 3. Patients who have not had a meaningful symptomatic improvement after 6 weeks of physical therapy 4. Patients who can consent to be a part of this study 5. Patients who are able to return to the Indiana Hand to Shoulder Center or a satellite location for follow up time points Exclusion Criteria: 1. Previous surgery to the lateral side of the elbow 2. Systemic inflammatory conditions (RA, psoriatic arthritis, lupus, etc) 3. Previous elbow injection within the last 6 months 4. History of recent elbow trauma 5. Patients actively involved in workman's compensation cases 6. Non-English Speaking Patients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 Control Group: standard corticosteroid injection: 1cc of celestone (6mg) diluted with 1 cc of 1% lidocaine and inject at the ECRB origin at area of maximal pain when palpated.\n\nGroup 2 Test Group: CTM injection: 1cc of CTM Boost will be diluted with 1 cc of 1% lidocaine and injected at the ECRB origin at area of maximal pain when palpated. CTM Boost is a connective tissue matrix suspended in saline. (injection will need to be with a 23 gauge needle and 3 cc syringe)\n\nRandomization will be through a computerized random allocation assigned by the Research Coordinator on the day of consent.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

2024-03-27