Efficacy of CTM for Tennis ELbow

Study Overview
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Brief Summary
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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.

Detailed Description
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Lateral Elbow Tendinopathy (LET) is considered an overload injury of the extensor tendons of the forearm where they attach at the lateral epicondyle. LET is a common condition encountered both in primary care and specialty clinics. A population-based study reported an incidence of 3.4 (95% CI, 3.3-3.5) per 1000. The highest incidence was among individuals aged 40 to 49 years, with 7.8 per 1000 in male patients and 10.2 per 1000 in female patients. Work restrictions were reported in 16% of the patients, and 4% reported missing 1 to 12 weeks of work. The recurrence rate within 2 years was 8.5% and remained constant over time. The study data suggest that patients without resolution after 6 months of onset may have a prolonged disease course and may need surgical intervention. The patient demographic is typically active in the workforce and LET related absenteeism results in a substantial economic impact. Pain relief, timely return to work, and avoidance of surgical intervention are therefore important LET treatment goals. Patients suffering from LET are grouped into 2 entities: Group 1 experience symptoms in an acute (tendinitis) phase that is largely influenced by the local inflammation stemming from over-use activities. Group 2 developed tendon degeneration and/or bony responses due to a persistent, chronic (tendinosis) pathology. Histologic specimens from chronic cases confirm that tendinosis is not an acute inflammatory condition but rather a failure of the normal tendon repair mechanism associated with angio-fibroblastic degeneration. The cause of elbow tendinosis is most likely a combination of mechanical overloading and abnormal microvascular responses. Further research into the precise cause of tendinosis is, however, still needed. The chief complaint in both groups is elbow pain with or without activity. Numerous methods have been advocated for treating LET including rest, nonsteroidal anti-inflammatory medication, bracing, physical therapy, iontophoresis, extracorporeal shock wave therapy, and botulism toxin. Injections of corticosteroids or whole blood, and various types of surgical procedures have also been recommended. The utility of several of these treatments has recently come into question. For example, one recent report noted that there is no difference between using corticosteroid or local anesthetic when treating elbow tendinosis with an injection. A recent review of common growth factors suggested human CTA may be useful for tendon and ligament healing in vivo. The primary study endpoint is based on the hypothesis that treatment of LET with a single application of CTA will provide a clinically meaningful improvement of the Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale Secondary endpoints include VAS pain and elbow range of motion. Secondary endpoints also include PROMIS scores of pain interference and depression. A single assessment numerical evaluation (SANE) of elbow function will also be obtained.

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

Conditions
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Tennis Elbow, Lateral Epicondylitis \(Tennis Elbow\), Lateral Elbow Tendinopathy

Intervention / Treatment
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* Device: CTM
* Drug: Celestone


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. Group 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) Randomization will be through a computerized random allocation assigned by the Research Coordinator on the day of consent.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Steroid Injection<br>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. | Drug: Celestone<br>* standard of care<br>* Other names: Corticosteroid;|
| Experimental: Test CTM Injection<br>Group 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) | Device: CTM<br>* 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.<br>* Other names: Connective Tissue Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale | PROM | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain | pain | 6 Months | 
| PROMIS Pain Interference | PROM | 6 Months | 
| PROMIS Depression | PROM | 6 Months | 
| Grip Strength | grip strength taken with a calibrated jamar instrument | 6 Months | 
| Range of Motion | wrist range of motion measured with a goniometer with elbow both flexed and extended | 6 Months |