Efficacy of CTM for Tennis ELbow

NCT06171555 | Unknown Phase 2 FDA Device

• 1 other identifier: IHTSC CTM Project HC22-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tennis Elbow; Lateral Epicondylitis \(Tennis Elbow\); Lateral Elbow Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale

  PROM

  6 Months

Secondary Outcomes (5)

• VAS Pain

  6 Months

• PROMIS Pain Interference

  6 Months

• PROMIS Depression

  6 Months

• Grip Strength

  6 Months

• Range of Motion

  6 Months

Study Arms (2)

Standard of Care Steroid Injection

ACTIVE COMPARATOR

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

Test CTM Injection

EXPERIMENTAL

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

Interventions

CTM DEVICE

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.

Also known as: Connective Tissue Matrix

Test CTM Injection

Celestone DRUG

standard of care

Also known as: Corticosteroid

Standard of Care Steroid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead
• CTM Biomedical: collaborator

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Betamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 14, 2023
• Study Start: January 26, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)