Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Biological: platelet rich plasma; Procedure: Arthroscopic rotator cuff repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04703998

5702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Arthroscopic rotator cuff repair and platelet rich plasma

Experimental group

Description:

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.

Treatment:

Procedure: Arthroscopic rotator cuff repair

Biological: platelet rich plasma

Arthroscopic rotator cuff repair

Active Comparator group

Description:

A standard double-row arthroscopic rotator cuff repair will be performed.

Treatment:

Procedure: Arthroscopic rotator cuff repair