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

University of Calgary104 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Rotator Cuff Injuries

Interventions

Platelet Rich Plasma (PRP)BIOLOGICAL

RegenLab, Lausanne, Switzerland

Corticosteroid (CS)DRUG

40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

visual analog scale for pain

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

Secondary Outcomes

American Shoulder and Elbow Surgeons shoulder score (ASES)

ASES score

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

Western Ontario Rotator Cuff Index (WORC)

WORC score

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

"Failure"

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

Time frame: anytime from injection out to 12 months

Anatomic changes

ultrasound evidence of progression to a full thickness tear

Time frame: 3 months and 12 months post injection

Data from ClinicalTrials.gov

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