drugset / Trial / NCT07456215
The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.
RandomizedParallel-groupTriple-blindBasic science
Summary
The aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear.
Timeline
- Start
- 2022-12-23
- Primary completion
- 2026-01-13
- Completion
- 2026-01-14
Publications
- Background Ahmad Z, Ang S, Rushton N, Harvey A, Akhtar K, Dawson-Bowling S, Noorani A. Platelet-Rich Plasma Augmentation of Arthroscopic Rotator Cuff Repair Lowers Retear Rates and Improves Short-Term Postoperative Functional Outcome Scores: A Systematic Review of Meta-Analyses. Arthrosc Sports Med Rehabil. 2022 Feb 5;4(2):e823-e833. doi: 10.1016/j.asmr.2021.12.012. eCollection 2022 Apr.
- Background Barber FA. PRP as an Adjunct to Rotator Cuff Tendon Repair. Sports Med Arthrosc Rev. 2018 Jun;26(2):42-47. doi: 10.1097/JSA.0000000000000193.
- Background Chalidis B, Givissis P, Papadopoulos P, Pitsilos C. Molecular and Biologic Effects of Platelet-Rich Plasma (PRP) in Ligament and Tendon Healing and Regeneration: A Systematic Review. Int J Mol Sci. 2023 Feb 1;24(3):2744. doi: 10.3390/ijms24032744.
- Background Dhillon MS, Behera P, Patel S, Shetty V. Orthobiologics and platelet rich plasma. Indian J Orthop. 2014 Jan;48(1):1-9. doi: 10.4103/0019-5413.125477.
- Background Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
- Background Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
- Background 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.
- Background Ho VP, Schiltz NK, Reimer AP, Madigan EA, Koroukian SM. High-Risk Comorbidity Combinations in Older Patients Undergoing Emergency General Surgery. J Am Geriatr Soc. 2019 Mar;67(3):503-510. doi: 10.1111/jgs.15682. Epub 2018 Dec 2.
- Background Hopewell S, Boutron I, Chan AW, Collins GS, de Beyer JA, Hrobjartsson A, Nejstgaard CH, Ostengaard L, Schulz KF, Tunn R, Moher D. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med. 2022 Sep;28(9):1740-1743. doi: 10.1038/s41591-022-01989-8. No abstract available.
- Background Jeno SH, Munjal A, Schindler GS. Anatomy, Shoulder and Upper Limb, Arm Supraspinatus Muscle. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537202/
- Background Kobayashi Y, Saita Y, Takaku T, Yokomizo T, Nishio H, Ikeda H, Takazawa Y, Nagao M, Kaneko K, Komatsu N. Platelet-rich plasma (PRP) accelerates murine patellar tendon healing through enhancement of angiogenesis and collagen synthesis. J Exp Orthop. 2020 Jul 8;7(1):49. doi: 10.1186/s40634-020-00267-1.
- Background Kovacevic D, Suriani RJ Jr, Levine WN, Thomopoulos S. Augmentation of Rotator Cuff Healing With Orthobiologics. J Am Acad Orthop Surg. 2022 Mar 1;30(5):e508-e516. doi: 10.5435/JAAOS-D-20-01011.
- Background Ladermann A, Burkhart SS, Hoffmeyer P, Neyton L, Collin P, Yates E, Denard PJ. Classification of full-thickness rotator cuff lesions: a review. EFORT Open Rev. 2017 Mar 13;1(12):420-430. doi: 10.1302/2058-5241.1.160005. eCollection 2016 Dec.
- Background Ladermann A, Meynard T, Denard PJ, Ibrahim M, Saffarini M, Collin P. Reliable diagnosis of posterosuperior rotator cuff tears requires a combination of clinical tests. Knee Surg Sports Traumatol Arthrosc. 2021 Jul;29(7):2118-2133. doi: 10.1007/s00167-020-06136-9. Epub 2020 Jul 28.
- Background Li S, Wu Y, Jiang G, Tian X, Hong J, Chen S, Yan R, Feng G, Cheng Z. Intratendon delivery of leukocyte-rich platelet-rich plasma at early stage promotes tendon repair in a rabbit Achilles tendinopathy model. J Tissue Eng Regen Med. 2020 Mar;14(3):452-463. doi: 10.1002/term.3006. Epub 2019 Dec 23.
- Background Liu F, Cheng X, Dong J, Zhou D, Han S, Yang Y. Comparison of MRI and MRA for the diagnosis of rotator cuff tears: A meta-analysis. Medicine (Baltimore). 2020 Mar;99(12):e19579. doi: 10.1097/MD.0000000000019579.
- Background Magra M, Maffulli N. Matrix metalloproteases: a role in overuse tendinopathies. Br J Sports Med. 2005 Nov;39(11):789-91. doi: 10.1136/bjsm.2005.017855. No abstract available.
- Background McNeilly CM, Banes AJ, Benjamin M, Ralphs JR. Tendon cells in vivo form a three dimensional network of cell processes linked by gap junctions. J Anat. 1996 Dec;189 ( Pt 3)(Pt 3):593-600.
- Background Mienaltowski MJ, Birk DE. Structure, physiology, and biochemistry of collagens. Adv Exp Med Biol. 2014;802:5-29. doi: 10.1007/978-94-007-7893-1_2.
- Background Peng Y, Guanglan W, Jia S, Zheng C. Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma in Rotator Cuff Repair: A Meta-analysis. Int J Sports Med. 2022 Oct;43(11):921-930. doi: 10.1055/a-1790-7982. Epub 2022 Mar 7.
- Background Ryosa A, Laimi K, Aarimaa V, Lehtimaki K, Kukkonen J, Saltychev M. Surgery or conservative treatment for rotator cuff tear: a meta-analysis. Disabil Rehabil. 2017 Jul;39(14):1357-1363. doi: 10.1080/09638288.2016.1198431. Epub 2016 Jul 6.
- Background Somerson JS, Hsu JE, Gorbaty JD, Gee AO. Classifications in Brief: Goutallier Classification of Fatty Infiltration of the Rotator Cuff Musculature. Clin Orthop Relat Res. 2016 May;474(5):1328-32. doi: 10.1007/s11999-015-4630-1. Epub 2015 Nov 19. No abstract available.
- Background Thorpe CT, Screen HR. Tendon Structure and Composition. Adv Exp Med Biol. 2016;920:3-10. doi: 10.1007/978-3-319-33943-6_1.
- Background Vosloo M, Keough N, De Beer MA. The clinical anatomy of the insertion of the rotator cuff tendons. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):359-366. doi: 10.1007/s00590-017-1922-z. Epub 2017 Feb 16.
- Background Xu W, Xue Q. Application of Platelet-Rich Plasma in Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jul 13;9(7):23259671211016847. doi: 10.1177/23259671211016847. eCollection 2021 Jul.
- Background Yang G, Rothrauff BB, Tuan RS. Tendon and ligament regeneration and repair: clinical relevance and developmental paradigm. Birth Defects Res C Embryo Today. 2013 Sep;99(3):203-222. doi: 10.1002/bdrc.21041.
- Background Yu TY, Pang JS, Lin LP, Cheng JW, Liu SJ, Tsai WC. Platelet-Rich Plasma Releasate Promotes Early Healing in Tendon After Acute Injury. Orthop J Sports Med. 2021 Apr 20;9(4):2325967121990377. doi: 10.1177/2325967121990377. eCollection 2021 Apr.
- Background Zhang J, Nie D, Williamson K, Rocha JL, Hogan MV, Wang JH. Selectively activated PRP exerts differential effects on tendon stem/progenitor cells and tendon healing. J Tissue Eng. 2019 Jan 16;10:2041731418820034. doi: 10.1177/2041731418820034. eCollection 2019 Jan-Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Platelet Rich Plasma | Other / unclassified | — | Other |