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

NCT04743986 | Completed Phase 4

• 1 other identifier: REB14-0570
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rotator Cuff Injuries

Keywords

corticosteroid; platelet rich plasma; tendinopathy; partial thickness tear

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  visual analog scale for pain

  change from baseline at 6 weeks, 3 months, 12 months

Secondary Outcomes (4)

• American Shoulder and Elbow Surgeons shoulder score (ASES)

  change from baseline at 6 weeks, 3 months, 12 months

• Western Ontario Rotator Cuff Index (WORC)

  change from baseline at 6 weeks, 3 months, 12 months

• "Failure"

  anytime from injection out to 12 months

• Anatomic changes

  3 months and 12 months post injection

Study Arms (2)

Platelet Rich Plasma (PRP)

EXPERIMENTAL

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)

Corticosteroid (CS)

ACTIVE COMPARATOR

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)

Interventions

Platelet Rich Plasma (PRP) BIOLOGICAL

RegenLab, Lausanne, Switzerland

Platelet Rich Plasma (PRP)

Corticosteroid (CS) DRUG

40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Corticosteroid (CS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (1)

• 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.

  PMID: 33127554 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Tendinopathy

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ian KY Lo, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC, Clinical Assistant Professor

Model Details: Two arm parallel randomized controlled trial

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: March 13, 2015
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share