NCT07456215

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tendon Injuries
• Supraspinatus Injury
• PRP

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Rich Plasma	The injection of PRP in the subacromial space.
OTHER	Normal saline	The injection of normal saline in the subacromial space.

Timeline

• Start date: 2022-12-23
• Primary completion: 2026-01-13
• Completion: 2026-01-14
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Greece