Connective Tissue Matrix for Rotator Cuff Tendinopathy

NCT06160427 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-264-FN
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.

Conditions

Tendinopathy; Shoulder Pain; Rotator Cuff Tendinitis; Rotator Cuff Tendinosis

Keywords

rotator cuff tendinopathy

Outcome Measures

Primary Outcomes (1)

• determine if injection of CTM Boost is non-inferior to injection of PRP

  Mean Western Ontario Rotator Cuff Index (WORC) Score The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.

  6 months

Secondary Outcomes (12)

• Mean Western Ontario Rotator Cuff Index (WORC) Score

  at 6 months

• assessment of superiority of CTM to PRP (if non-inferiority established)/ WORC Score

  Each visit up to 24 months

• assessment of superiority of CTM to PRP (if non-inferiority established) / VAS Pain Scale

  Each visit up to 24 months

• assessment of superiority of CTM to PRP (if non-inferiority established) / SANE

  Each visit up to 24 months

• assessment of superiority of CTM to PRP (if non-inferiority established) / ASES

  Each visit up to 24 months

Study Arms (2)

CTM Treatment

EXPERIMENTAL

2.0 cc (cubic centimeter) dose injection of CTM Boost will be administered by injection directly into the rotator cuff using a 20 gauge needle.

Biological: CTM Boost

PRP Treatment

ACTIVE COMPARATOR

Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).

Biological: PRP

Interventions

CTM Boost BIOLOGICAL

Connective Tissue Matrix (CTM) Boost is a decellularized Human Cellular and Tissue Based Allograft derived from placental connective tissue. It is considered a minimally-manipulated biologic by the FDA and is marketed as an allograft for repairing connective tissue. It is administered via injection.

CTM Treatment

PRP BIOLOGICAL

PRP is derived by a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing. At baseline, a blood draw of 60 milliliter (mL) will be obtained and concentrated in an Angel System to yield 5 cc of PRP and a supra-physiological concentration of white blood cells. All injections will be done under ultrasound guidance. A two-part injection process will be used. An advancing 20 gauge 1.5-inch needle first placed 3 mL of 1% xylocaine proximal to the tendinopathic area or tear. The needle will then be re-inserted at the proximal aspect of the lesion and slowly removed while infiltrating of 5 mL of PRP without activation with Calcium Chloride/thrombin at the lesion and surrounding tendon.

PRP Treatment

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 PRP 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 any medical conditions that affect healing, such as end-stage renal disease or uncontrolled diabetes

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Connective Tissue Matrix Biomedical, LLC: collaborator

Study Sites (4)

Allegheny Health Network Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Allegheny Health Network Federal North Medical Office Building

Pittsburgh, Pennsylvania, 15212, United States

Location

AHN Wexford Health & Wellness Pavilion

Wexford, Pennsylvania, 15090, United States

Location

AHN Wexford Hospital

Wexford, Pennsylvania, 15090, United States

Location

Related Publications (12)

• A Hamid MS, Sazlina SG. Platelet-rich plasma for rotator cuff tendinopathy: A systematic review and meta-analysis. PLoS One. 2021 May 10;16(5):e0251111. doi: 10.1371/journal.pone.0251111. eCollection 2021.

  PMID: 33970936 BACKGROUND

• Lin MT, Wei KC, Wu CH. Effectiveness of Platelet-Rich Plasma Injection in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Diagnostics (Basel). 2020 Mar 28;10(4):189. doi: 10.3390/diagnostics10040189.

  PMID: 32231127 BACKGROUND

• Gotoh M, Hamada K, Yamakawa H, Yanagisawa K, Nakamura M, Yamazaki H, Ueyama Y, Tamaoki N, Inoue A, Fukuda H. Interleukin-1-induced subacromial synovitis and shoulder pain in rotator cuff diseases. Rheumatology (Oxford). 2001 Sep;40(9):995-1001. doi: 10.1093/rheumatology/40.9.995.

  PMID: 11561109 BACKGROUND

• Gotoh M, Hamada K, Yamakawa H, Nakamura M, Yamazaki H, Ueyama Y, Tamaoki N, Inoue A, Fukuda H. Perforation of rotator cuff increases interleukin 1beta production in the synovium of glenohumeral joint in rotator cuff diseases. J Rheumatol. 2000 Dec;27(12):2886-92.

  PMID: 11128681 BACKGROUND

• Yanagisawa K, Hamada K, Gotoh M, TokunagaT, Oshika Y, Tomisawa M, Lee YH, Handa A, Kijima H, Yamazaki H, Nakamura M, Ueyama Y, Tamaoki N, Fukuda H. Vascular endothelial growth factor (VEGF) expression in the subacromial bursa is increased in patients with impingement syndrome. J Orthop Res. 2001 May;19(3):448-55. doi: 10.1016/S0736-0266(00)90021-4.

  PMID: 11398859 BACKGROUND

• Sachinis NP, Yiannakopoulos CK, Chalidis B, Kitridis D, Givissis P. Biomolecules Related to Rotator Cuff Pain: A Scoping Review. Biomolecules. 2022 Jul 22;12(8):1016. doi: 10.3390/biom12081016.

  PMID: 35892325 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Scarpone M, Rabago D, Snell E, Demeo P, Ruppert K, Pritchard P, Arbogast G, Wilson JJ, Balzano JF. Effectiveness of Platelet-rich Plasma Injection for Rotator Cuff Tendinopathy: A Prospective Open-label Study. Glob Adv Health Med. 2013 Mar;2(2):26-31. doi: 10.7453/gahmj.2012.054.

  PMID: 24416661 BACKGROUND

• 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 BACKGROUND

• Bushnell BD, Bishai SK, Krupp RJ, McMillan S, Schofield BA, Trenhaile SW, McIntyre LF. Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry. Orthop J Sports Med. 2021 Aug 13;9(8):23259671211027850. doi: 10.1177/23259671211027850. eCollection 2021 Aug.

  PMID: 34409115 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

Related Links

• Sealed Envelope \| Power calculator for continuous outcome non-inferiority trial
• Daines R. LibGuides: Statistics Resources: Partial Eta Squared

MeSH Terms

Conditions

Tendinopathy; Shoulder Pain; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Shoulder Injuries

Study Officials

• Patrick Demeo, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomized to one of the two arms by unblinded research personnel. Unblinded key study personnel will prepare the injection of either CTM Boost or PRP using an opaque sleeve to obscure the contents of the injection. Both patients and investigators will be blinded to treatment arm. Each participant will undergo an antecubital blood draw of 60 milliliers (mL). Staff will wait about 20 minutes after the blood draw to injection time. This will be done to maintain blinding due to the 17 minutes it takes for the system to produce PRP. For patients in the CTM arm, the PRP blood draw serves as a placebo draw and the specimen will be discarded afterwards, in order to maintain blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Institute Chair of the Department of Orthopaedic Surgery

Model Details: Two-arm, double-blinded, randomized controlled trial with the primary objective of evaluating non-inferiority of CTM (study intervention arm) to PRP (active comparator arm) for rotator cuff tendinopathy pain and function.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)