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Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

NCT ID: NCT04703998

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-03

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arthroscopic rotator cuff repair and 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.

Group Type EXPERIMENTAL

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

A double-row rotator cuff repair will be performed.

platelet rich plasma

Intervention Type BIOLOGICAL

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

Arthroscopic rotator cuff repair

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

Group Type ACTIVE_COMPARATOR

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

A double-row rotator cuff repair will be performed.

Interventions

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Arthroscopic rotator cuff repair

A double-row rotator cuff repair will be performed.

Intervention Type PROCEDURE

platelet rich plasma

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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LUCIANO ANDRES ROSSI

Pincipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luciano Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires

CABA, , Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 38587033 (View on PubMed)

Other Identifiers

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5702

Identifier Type: -

Identifier Source: org_study_id