Clinical trial NCT04743986: The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Official title: The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotator Cuff Injuries
Keywords: corticosteroid
platelet rich plasma
tendinopathy
partial thickness tear
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm parallel randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: change from baseline at 6 weeks, 3 months, 12 months
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons shoulder score (ASES)
timeFrame: change from baseline at 6 weeks, 3 months, 12 months
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: change from baseline at 6 weeks, 3 months, 12 months
measure: "Failure"
timeFrame: anytime from injection out to 12 months
measure: Anatomic changes
timeFrame: 3 months and 12 months post injection
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Ian KY Lo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.