Rotator Cuff Tears
Conditions
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.
Interventions
PROCEDUREArthroscopic rotator cuff repair
A double-row rotator cuff repair will be performed.
BIOLOGICALplatelet rich plasma
A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of re-tear rates between groups. | 6 months | Postoperative MRI to assess the structural integrity of the repaired rotator cuff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Argentina
Outcome results
None listed