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

NCT07689383 | Completed Phase 2

• 1 other identifier: 18/08-06-2021
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear; PRP Injection; Rotator Cuff Repair of the Shoulder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

PRP Treatment Group

EXPERIMENTAL

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; Biological: PRP injection

Control group

ACTIVE COMPARATOR

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

Interventions

Arthroscopic repair of shoulder rotator cuff tear PROCEDURE

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.

Control group; PRP Treatment Group

PRP injection BIOLOGICAL

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.

PRP Treatment Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KAT General Hospital: lead

Study Sites (1)

KAT General Hospital

Kifissia, Attica, 14561, Greece

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ioannis Angelos Trantos, MD, MSc

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: November 20, 2021
• Primary Completion: February 2, 2026
• Study Completion: May 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

GR (1)