Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
92 participants
INTERVENTIONAL
2023-12-04
2028-01-15
Brief Summary
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Detailed Description
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The advent of platelet rich plasma (PRP), a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing, has shown promise as another treatment modality when injected at the site of tendon damage. Placenta-derived decellularized connective tissue matrix (CTM) may represent an alternative therapy for RCT. Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro, thus potentially accelerating and enhancing tendon healing.
This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
Study Groups
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CTM Treatment
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.
CTM Boost
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.
PRP Treatment
Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).
PRP
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.
Interventions
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CTM Boost
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.
PRP
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Connective Tissue Matrix Biomedical, LLC
UNKNOWN
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
Responsible Party
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Patrick DeMeo, MD
Professor and Institute Chair of the Department of Orthopaedic Surgery
Principal Investigators
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Patrick Demeo, MD
Role: PRINCIPAL_INVESTIGATOR
Allegheny Health Network
Locations
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Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network Federal North Medical Office Building
Pittsburgh, Pennsylvania, United States
AHN Wexford Health & Wellness Pavilion
Wexford, Pennsylvania, United States
AHN Wexford Hospital
Wexford, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Sealed Envelope \| Power calculator for continuous outcome non-inferiority trial
Daines R. LibGuides: Statistics Resources: Partial Eta Squared
Other Identifiers
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2023-264-FN
Identifier Type: -
Identifier Source: org_study_id
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