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

NCT ID: NCT04743986

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-13
• Study Completion Date: 2019-06-06

Brief Summary

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

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.

Conditions

Rotator Cuff Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet Rich Plasma (PRP)

Intervention Type: BIOLOGICAL

RegenLab, Lausanne, Switzerland

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.

Group Type: ACTIVE_COMPARATOR

Corticosteroid (CS)

Intervention Type: DRUG

40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Interventions

Platelet Rich Plasma (PRP)

RegenLab, Lausanne, Switzerland

Intervention Type: BIOLOGICAL

Corticosteroid (CS)

40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Ian King Yeung Lo

MD, FRCSC, Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian KY Lo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

References

Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.

Reference Type: BACKGROUND

PMID: 33127554 (View on PubMed)

Other Identifiers

REB14-0570

Identifier Type: -

Identifier Source: org_study_id