The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.

March 4, 2026 updated by: Aristotle University Of Thessaloniki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The refractory to conservative treatment rotator cuff tears are mainly treated with arthroscopic repair. Intraoperative or postoperative platelet rich plasma (PRP) injections have been widely used to enhance the tendon healing and the repair process. Additionally, subacromial PRP injections are related to favorable outcomes in case of partial rotator cuff tears even one month after their application. Laboratory and clinical trials have correlated PRP with an increase in tenocyte metabolic activity, based on the up- or downregulation of specific gene expression.

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.

The included patients will undergo an ultrasound-assisted PRP or saline subacromial injection, four to six weeks prior to the scheduled surgery. During the arthroscopic rotator cuff repair procedure, a tendon biopsy will be performed and the sample will be sent for further analysis.

The samples will be sent for histologic analysis and quantification of specific gene expression. The gene analysis will contain the collagen I, collagen III, metalloproteinase 3 and metalloproteinase 13 genes, which are related to tendon repair and remodeling in cases of rupture and/or injury. Furthermore, the two groups will be compared in terms of the MRI imaging findings. After statistical analysis, a conclusion regarding the effect of PRP on the enhancement of biological properties of the ruptured tendon and, consecutively, tendon healing process will be extracted.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Cental Macedonia
      • Thessaloniki, Cental Macedonia, Greece, 54635
        • Charalampos Pitsilos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP group
The experimental group includes patients to whom the PRP intervention will be applied.
Biological: Platelet Rich Plasma
The injection of PRP in the subacromial space.
Other Names:
  • PRP
Placebo Comparator: Control group
The control group includes patients to whom a normal saline injection will be applied.
Other: Normal saline
The injection of normal saline in the subacromial space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movin score
Time Frame: Immediately after surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bonar score
Time Frame: Immediately after surgery.
The Bonar score qualifies the characteristics of tendon structure, including : tenocytes, collagen, ground substance and vascularity. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Collagen I gene expression
Time Frame: Immediately after surgery.
Collagen I gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Collagen II expression
Time Frame: Immediately after surgery.
Collagen II expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Collagen III gene expression
Time Frame: Immediately after surgery.
Collagen IIII expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Metalloproteinase 3 gene expression
Time Frame: Immediately after surgery.
Metalloproteinase 3 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Metalloproteinase 13 gene expression
Time Frame: Immediately after surgery.
Metalloproteinase 13 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Interleukin 1β gene expression
Time Frame: Immediately after surgery.
Interleukin 1β gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.
Interleukin 6 gene expression
Time Frame: Immediately after surgery.
Interleukin 6 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Immediately after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Charalampos Pitsilos, MSc, Aristotle University Of Thessaloniki
  • Study Chair: Pericles Papadopoulos, PhD, Aristotle University Of Thessaloniki
  • Study Director: Ioannis Gigis, PhD, Aristotle University Of Thessaloniki
  • Study Director: Byron Chalidis, PhD, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2022

Primary Completion (Actual)

January 13, 2026

Study Completion (Actual)

January 14, 2026

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP: Effect on Tendon Biology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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