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Completed

NCT Number: NCT04703998

Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

CABA, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Rotator Cuff Repair

Procedure

A double-row rotator cuff repair will be performed.

Platelet rich plasma

Biological

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

Primary outcomes

  1. Comparison of re-tear rates between groups.

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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."

  3. Number of Participants With Treatment-Related Adverse Events

    Time frame: 3, 6, and 12 months

    Adverse effects and postoperative complications will be recorded.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2021
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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