Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Hospital Italiano de Buenos Aires103 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

103

Conditions

Rotator Cuff Tears

Interventions

Arthroscopic rotator cuff repairPROCEDURE

A double-row rotator cuff repair will be performed.

platelet rich plasmaBIOLOGICAL

A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Italiano de Buenos Aires

CABA, Argentina

Outcomes

Primary Outcomes

Comparison of re-tear rates between groups.

Postoperative MRI to assess the structural integrity of the repaired rotator cuff.

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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."

Time frame: baseline, 3, 6, and 12 months

Number of Participants With Treatment-Related Adverse Events

Adverse effects and postoperative complications will be recorded.

Time frame: 3, 6, and 12 months

Data from ClinicalTrials.gov

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