The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study

Purpose of the study:

The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.

What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear; Rotator Cuff Repair of the Shoulder; PRP Injection
• Intervention / Treatment: Procedure: Arthroscopic repair of shoulder rotator cuff tear; Biological: PRP injection

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Kifissia, Attica, Greece, 14561
      • KAT General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.

Exclusion Criteria:

a) acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP Treatment Group; The patients underwent arthroscopic repair of rotator cuff tear. They were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months.	Procedure: Arthroscopic repair of shoulder rotator cuff tear; All patients received general anesthesia and were operated on in the "beach chair" position. Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary. In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed. Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed. Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed. Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal. The patients of both groups followed the same postoperative rehabilitation protocol.; Biological: PRP injection; The patients of treatment goup were administered a single intraarticular PRP injection in the operated shoulder at 10-15 days postoperatively. An autologous sample of 9 ml of peripheral blood was collected, and after addition of anticoagulant and preparation with a centrifuge for 6 minutes, 4ml of PRP was received and injected intraarticularly in a subacromial fashion.
Active Comparator: Control group; The patients underwent arthroscopic repair of rotator cuff tear. They did not receive any shoulder injection postoperatively. The postoperative protocol included using a shoulder sling with no active range of motion for four weeks, followed by a rehabilitation program of progressive active-assisted, active range of motion (ROM) and muscle strengthening for two months.	Procedure: Arthroscopic repair of shoulder rotator cuff tear; All patients received general anesthesia and were operated on in the "beach chair" position. Concerning the arthroscopic rotator cuff repair, systematic glenohumeral joint and subacromial exploration were performed, and lesions were managed as necessary. In each case, after the frayed and atrophied torn end was removed, the rotator cuff tear was carefully evaluated, and anteroposterior size, mediolateral retraction, number of involved tendons, visual tendon grade, excursion, and presence of the subscapularis tear were assessed. Debridement of bursal tissue and subacromial and distal clavicle osteophytes was minimally performed. Extensive acromioplasty to flatten a hooked or curved acromion was rarely performed. Rotator cuff repair was performed to cover the original footprint using suture anchors that were inserted through the accessory portal. The patients of both groups followed the same postoperative rehabilitation protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of Constant - Murley score	at 3, 6 and 12 months postoperatively
Change from baseline of ASES score	at 3, 6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of shoulder rotator cuff tendon retears	at 6 months postoperatively
Measurement of pain on a Numerical Rating Scale (NRS) of 0 to 15	at 1 month postoperatively

Collaborators and Investigators

• Sponsor: KAT General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Actual): February 2, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 18/08-06-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No