Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Rotator Cuff Tears Clinical Trial

Official title:

Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703998
• Other study ID #: 5702
• Status: Completed
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2022
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Arthroscopic rotator cuff repair
A double-row rotator cuff repair will be performed.

Biological:
• platelet rich plasma
A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of re-tear rates between groups.	Postoperative MRI to assess the structural integrity of the repaired rotator cuff.	6 months
Secondary	Change From baseline in shoulder functional scores at 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	baseline, 3, 6, and 12 months
Secondary	Change From baseline in pain at 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."	baseline, 3, 6, and 12 months
Secondary	Number of Participants With Treatment-Related Adverse Events	Adverse effects and postoperative complications will be recorded.	3, 6, and 12 months