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Completed

NCT Number: NCT04743986

The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial

Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.

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Key information

Conditions

Rotator Cuff Injuries Muscular Diseases Musculoskeletal Diseases Rupture Shoulder Injuries Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >18 years
  • MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
  • symptomatic for minimum of 3 months
  • patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)

Exclusion criteria

  • prior surgical intervention on affected shoulder
  • full thickness rotator cuff tear
  • concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
  • confounding cervical neck pain or radiculopathy
  • more than 3 previous CS injections
  • a CS injection within 6 months of study intervention
  • elite level athlete
  • worker's compensation case
  • litigation or secondary gain issues
  • unwilling or unable to provide informed consent or complete study outcomes

Treatment and study plan

Platelet Rich Plasma (PRP)

Biological

RegenLab, Lausanne, Switzerland

Corticosteroid (CS)

Drug

40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: change from baseline at 6 weeks, 3 months, 12 months

    visual analog scale for pain

Secondary outcomes

  1. American Shoulder and Elbow Surgeons shoulder score (ASES)

    Time frame: change from baseline at 6 weeks, 3 months, 12 months

    ASES score

  2. Western Ontario Rotator Cuff Index (WORC)

    Time frame: change from baseline at 6 weeks, 3 months, 12 months

    WORC score

  3. "Failure"

    Time frame: anytime from injection out to 12 months

    • patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery

  4. Anatomic changes

    Time frame: 3 months and 12 months post injection

    ultrasound evidence of progression to a full thickness tear

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: PRP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2021
Registry last updated
Feb 8, 2021

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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