Skip to main content
OpenTrials
Completed

NCT Number: NCT07456215

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charalampos Pitsilos

Thessaloniki, Cental Macedonia, 54635, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Biological

The injection of PRP in the subacromial space.

Other names: PRP

Normal Saline

Other

The injection of normal saline in the subacromial space.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.