Connective Tissue Matrix Compared to Steroid Injections for Rotator Cuff Tendinopathy

NCT06712290 | Withdrawn

• 1 other identifier: 2024-118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot. Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in. Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.

Conditions

Rotator Cuff Tendinopathy

Keywords

Shoulder; Rotator cuff; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Raw WORC Score at 3 Month Visit

  The primary outcome will be raw WORC score at the Month 3 visit. WORC is a patient-reported quality of life outcome measure for patients with rotator cuff disorders. The raw score obtained from scoring a completed questionnaire ranges from 0 to 2100, where higher scores indicate poorer quality of life.

  3 Month Visit

Secondary Outcomes (9)

• WORC Score

  Baseline, Week 6, Month 3, Month 6 Visits

• VAS: The Visual Analogue Scale

  Baseline, Week 6, Month 3, Month 6 Visits

• SANE: The Single Assessment Numeric Evaluation

  Baseline, Week 6, Month 3, Month 6 Visits

• ASES

  Baseline, Week 6, Month 3, Month 6 Visits

• Functional Assessments: Empty can exercise

  Baseline, Week 6, Month 3, Month 6 Visits

Study Arms (2)

Corticosteroid

PLACEBO COMPARATOR

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Drug: Corticosteroid

CTM Boost

EXPERIMENTAL

TM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Drug: celgene

Interventions

Corticosteroid DRUG

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Also known as: kenalog

Corticosteroid

celgene DRUG

CTM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Also known as: CTM boost

CTM Boost

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years old with rotator cuff tendinopathy
• A corticosteroid or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection

You may not qualify if:

• Patients with adhesive capsulitis
• Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
• Patients with joint instability
• History of shoulder surgery or corticosteroid injection in the past 3 months
• Patients with a history of chronic steroid treatment for any medical reason
• Patients with medical conditions that may affect healing, such as
• End-stage renal disease
• Uncontrolled diabetes
• Peripheral vascular disease
• Severe and/or systemic immunocompromising conditions such as Lupus or HIV infection
• Patients who are pregnant or breast feeding

Sponsors & Collaborators

• CTM Biomedical: collaborator
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny Health Network Federal North Medical Office Building

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (4)

• Braun C, Handoll HH. Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears. Musculoskelet Sci Pract. 2018 Jun;35:30-33. doi: 10.1016/j.msksp.2018.02.003. Epub 2018 Feb 12.

  PMID: 29471221 RESULT

• Chen J, Svensson J, Sundberg CJ, Ahmed AS, Ackermann PW. FGF gene expression in injured tendons as a prognostic biomarker of 1-year patient outcome after Achilles tendon repair. J Exp Orthop. 2021 Mar 11;8(1):20. doi: 10.1186/s40634-021-00335-0.

  PMID: 33694106 RESULT

• Dean BJ, Snelling SJ, Dakin SG, Murphy RJ, Javaid MK, Carr AJ. Differences in glutamate receptors and inflammatory cell numbers are associated with the resolution of pain in human rotator cuff tendinopathy. Arthritis Res Ther. 2015 Jul 10;17(1):176. doi: 10.1186/s13075-015-0691-5.

  PMID: 26160609 RESULT

• Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.

  PMID: 33375716 RESULT

MeSH Terms

Conditions

Tendinopathy

Interventions

Adrenal Cortex Hormones; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: November 25, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)