PRP Injection, Rotator Cuff Repair of the Shoulder, Rotator Cuff Tear
Conditions
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.
Interventions
PROCEDUREArthroscopic 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.
BIOLOGICALPRP 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.
Sponsors
KAT General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
Greece
Outcome results
None listed