Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
- Conditions
- Rotator Cuff Tears
- Interventions
- Procedure: Arthroscopic rotator cuff repairBiological: platelet rich plasma
- Registration Number
- NCT04703998
- Lead Sponsor
- Hospital Italiano de Buenos Aires
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arthroscopic rotator cuff repair and platelet rich plasma Arthroscopic rotator cuff repair 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. Arthroscopic rotator cuff repair and platelet rich plasma platelet rich plasma 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. Arthroscopic rotator cuff repair Arthroscopic rotator cuff repair A standard double-row arthroscopic rotator cuff repair will be performed.
- Primary Outcome Measures
Name Time Method Comparison of re-tear rates between groups. 6 months Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
- Secondary Outcome Measures
Name Time Method Change From baseline in pain at 3, 6 and 12 months baseline, 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."
Number of Participants With Treatment-Related Adverse Events 3, 6, and 12 months Adverse effects and postoperative complications will be recorded.
Change From baseline in shoulder functional scores at 3, 6 and 12 months baseline, 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
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires
🇦🇷Caba, Argentina