Status:
COMPLETED
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
50-75 years
Phase:
NA
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 ...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04703998
Start Date
January 3 2021
End Date
September 1 2022
Last Update
December 22 2022
Active Locations (1)
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1
Hospital Italiano de Buenos Aires
CABA, Argentina