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

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ClinicalTrials.gov Identifier: NCT04743986
Recruitment Status : Completed
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ian King Yeung Lo, University of Calgary

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Injuries Biological: Platelet Rich Plasma (PRP) Drug: Corticosteroid (CS) Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm parallel randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
Primary Purpose: Treatment
Official Title: The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Actual Study Start Date : March 13, 2015
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet Rich Plasma (PRP)
Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection.
Biological: Platelet Rich Plasma (PRP)
RegenLab, Lausanne, Switzerland

Active Comparator: Corticosteroid (CS)
Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself.
Drug: Corticosteroid (CS)
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: change from baseline at 6 weeks, 3 months, 12 months ]
    visual analog scale for pain


Secondary Outcome Measures :
  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 ]
    1) 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743986


Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Ian KY Lo, MD University of Calgary
Publications:
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Responsible Party: Ian King Yeung Lo, MD, FRCSC, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04743986    
Other Study ID Numbers: REB14-0570
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Ian King Yeung Lo, University of Calgary:
corticosteroid
platelet rich plasma
tendinopathy
partial thickness tear
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries