Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Study Overview
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Brief Summary
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Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.

Detailed Description
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Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.

Official Title
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Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: Arthroscopic rotator cuff repair
* Biological: platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI). Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids) Exclusion Criteria: Refusal to participate or informed consent, Revision surgery, Partial repair, Patients with shoulder osteoarthritis> 2 Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4) Systemic or rheumatoid arthritis, Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist) Acute or chronic infections of the shoulder to be operated on Ongoing cancer chemotherapy therapies Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes; Previous operations on the affected shoulder, Patients with autoimmune diseases; Pregnant

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopic rotator cuff repair and platelet rich plasma<br>A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface. | Procedure: Arthroscopic rotator cuff repair<br>* A double-row rotator cuff repair will be performed.<br>Biological: platelet rich plasma<br>* A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.<br>|
| Active Comparator: Arthroscopic rotator cuff repair<br>A standard double-row arthroscopic rotator cuff repair will be performed. | Procedure: Arthroscopic rotator cuff repair<br>* A double-row rotator cuff repair will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of re-tear rates between groups. | Postoperative MRI to assess the structural integrity of the repaired rotator cuff. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From baseline in shoulder functional scores at 3, 6 and 12 months | The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology | baseline, 3, 6, and 12 months | 
| Change From baseline in pain at 3, 6 and 12 months | The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as no pain and 10 as the worst pain of his life. | baseline, 3, 6, and 12 months | 
| Number of Participants With Treatment-Related Adverse Events | Adverse effects and postoperative complications will be recorded. | 3, 6, and 12 months |