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

Phase 4

Completed

• Conditions: Rotator Cuff Injuries
• Interventions: Drug: Corticosteroid (CS); Biological: Platelet Rich Plasma (PRP)

• Registration Number: NCT04743986
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2015-03-13
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-08
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid (CS)	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.
Platelet Rich Plasma (PRP)	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	change from baseline at 6 weeks, 3 months, 12 months	visual analog scale for pain

Secondary Outcome Measures

Name	Time	Method
"Failure"	anytime from injection out to 12 months	1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery
Anatomic changes	3 months and 12 months post injection	ultrasound evidence of progression to a full thickness tear
American Shoulder and Elbow Surgeons shoulder score (ASES)	change from baseline at 6 weeks, 3 months, 12 months	ASES score
Western Ontario Rotator Cuff Index (WORC)	change from baseline at 6 weeks, 3 months, 12 months	WORC score