Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears
- Sponsor
- Hospital Italiano de Buenos Aires
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Comparison of re-tear rates between groups.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
LUCIANO ANDRES ROSSI
Pincipal investigator
Hospital Italiano de Buenos Aires
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Comparison of re-tear rates between groups.
Time Frame: 6 months
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
Secondary Outcomes
- Number of Participants With Treatment-Related Adverse Events(3, 6, and 12 months)
- Change From baseline in shoulder functional scores at 3, 6 and 12 months(baseline, 3, 6, and 12 months)
- Change From baseline in pain at 3, 6 and 12 months(baseline, 3, 6, and 12 months)