NCT07456215

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

March 31, 2023

Last Update Submit

March 4, 2026

Conditions

Supraspinatus InjuryPRPTendon Injuries

Keywords

Supraspinatus tendonBiologyCollagenMetalloproteinaseTenocytePRPPlatelet Rich PlasmaGene expressionShoulder injection

Outcome Measures

Primary Outcomes (1)

  • Movin score

    The Movin score qualifies the characteristics of tendon structure, including : fiber arrangement, fiber structure, rounding of the nuclei, inflammation, angiogenesis and cell density. The scores of the experimental and control groups will be compared.

    Immediately after surgery.

Secondary Outcomes (8)

  • Bonar score

    Immediately after surgery.

  • Collagen I gene expression

    Immediately after surgery.

  • Collagen II expression

    Immediately after surgery.

  • Collagen III gene expression

    Immediately after surgery.

  • Metalloproteinase 3 gene expression

    Immediately after surgery.

  • +3 more secondary outcomes

Study Arms (2)

PRP group

EXPERIMENTAL

The experimental group includes patients to whom the PRP intervention will be applied.

Biological: Platelet Rich Plasma

Control group

PLACEBO COMPARATOR

The control group includes patients to whom a normal saline injection will be applied.

Other: Normal saline

Interventions

Platelet Rich PlasmaBIOLOGICAL

The injection of PRP in the subacromial space.

Also known as: PRP
PRP group
Normal salineOTHER

The injection of normal saline in the subacromial space.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full thickness rotator cuff tear treated with arthroscopic repair
  • Age of 18 to 65 years
  • Chronic shoulder pain due to rotator cuff tear
  • Magnetic resonance imaging study within 6 months prior to arthroscopy
  • Goutallier grade 1 or 2 muscle fatty infiltration

You may not qualify if:

  • Comorbidities, including coagulopathy, liver disease, cancer, nutritional disorder
  • Goutallier grade 3 or 4 muscle fatty infiltration
  • Shoulder osteoarthritis, rotator cuff arthropathy, rheumatoid arthritis
  • History oof shoulder injection within the last 12 months
  • History of prior shoulder surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charalampos Pitsilos

Thessaloniki, Cental Macedonia, 54635, Greece

Location

Related Publications (28)

  • 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.

    PMID: 35494273BACKGROUND

  • 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.

    PMID: 29722762BACKGROUND

  • 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.

    PMID: 36769065BACKGROUND

  • 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.

    PMID: 24600055BACKGROUND

  • 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.

    PMID: 25722595BACKGROUND

  • 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.

    PMID: 19187989BACKGROUND

  • 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: 33375716BACKGROUND

  • 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.

    PMID: 30506953BACKGROUND

  • 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.

    PMID: 36109642BACKGROUND

  • 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/

    PMID: 30725887BACKGROUND

  • 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.

    PMID: 32642866BACKGROUND

  • 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.

    PMID: 34932515BACKGROUND

  • 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.

    PMID: 28461921BACKGROUND

  • 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.

    PMID: 32725446BACKGROUND

  • 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.

    PMID: 31840415BACKGROUND

  • 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.

    PMID: 32195972BACKGROUND

  • 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.

    PMID: 16244185BACKGROUND

  • 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.

    PMID: 8982835BACKGROUND

  • 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.

    PMID: 24443018BACKGROUND

  • 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.

    PMID: 35255508BACKGROUND

  • 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.

    PMID: 27385156BACKGROUND

  • 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.

    PMID: 26584800BACKGROUND

  • 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.

    PMID: 27535244BACKGROUND

  • 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.

    PMID: 28204962BACKGROUND

  • 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.

    PMID: 34345632BACKGROUND

  • 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.

    PMID: 24078497BACKGROUND

  • 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.

    PMID: 33959667BACKGROUND

  • 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.

    PMID: 30728936BACKGROUND

MeSH Terms

Conditions

Tendon Injuries

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Charalampos Pitsilos, MSc

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

  • Pericles Papadopoulos, PhD

    Aristotle University Of Thessaloniki

    STUDY CHAIR

  • Ioannis Gigis, PhD

    Aristotle University Of Thessaloniki

    STUDY DIRECTOR

  • Byron Chalidis, PhD

    Aristotle University Of Thessaloniki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

March 6, 2026

Study Start

December 23, 2022

Primary Completion

January 13, 2026

Study Completion

January 14, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

After the collection and statistical analysis of the results of this clinical trial, the data will be published in scientific or medical journals.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After data collection and statistical analysis. Within three years from the beginning of this study and will be available for 6 months after publication.
Access Criteria
Every individual who has access to ClinicalTrials.gov will have permission to requests the available data. The permission will be given by one of the investigators of this clinical trial.

Locations

GR(1)