Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

NCT04703998 | Completed

• 1 other identifier: 5702
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Comparison of re-tear rates between groups.

  Postoperative MRI to assess the structural integrity of the repaired rotator cuff.

  6 months

Secondary Outcomes (3)

• Change From baseline in shoulder functional scores at 3, 6 and 12 months

  baseline, 3, 6, and 12 months

• Change From baseline in pain at 3, 6 and 12 months

  baseline, 3, 6, and 12 months

• Number of Participants With Treatment-Related Adverse Events

  3, 6, and 12 months

Study Arms (2)

Arthroscopic rotator cuff repair and platelet rich plasma

EXPERIMENTAL

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.

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

Arthroscopic rotator cuff repair

ACTIVE COMPARATOR

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

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repair PROCEDURE

A double-row rotator cuff repair will be performed.

Arthroscopic rotator cuff repair; Arthroscopic rotator cuff repair and platelet rich plasma

platelet rich plasma BIOLOGICAL

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

Arthroscopic rotator cuff repair and platelet rich plasma

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

CABA, Argentina

Location

Related Publications (1)

• Rossi LA, Gorodischer TD, Camino P, Brandariz RN, Tanoira I, Piuzzi NS, Ranalletta M. Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate But Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 May;52(6):1403-1410. doi: 10.1177/03635465241239062. Epub 2024 Apr 8.

  PMID: 38587033 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Luciano Rossi, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pincipal investigator

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 11, 2021
• Study Start: January 3, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2 years
• Access Criteria: The IPD may be requested to the principal investigator contacting him through e-mail at luciano.rossi@hospitalitaliano.org.ar

Locations

AR (1)