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

Rotator Cuff Injuries Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743986
• Other study ID #: REB14-0570
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2015
• Est. completion date: June 6, 2019

Study information

• Verified date: February 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

Biological:
• Platelet Rich Plasma (PRP)
RegenLab, Lausanne, Switzerland

Drug:
• Corticosteroid (CS)
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	visual analog scale for pain	change from baseline at 6 weeks, 3 months, 12 months
Secondary	American Shoulder and Elbow Surgeons shoulder score (ASES)	ASES score	change from baseline at 6 weeks, 3 months, 12 months
Secondary	Western Ontario Rotator Cuff Index (WORC)	WORC score	change from baseline at 6 weeks, 3 months, 12 months
Secondary	"Failure"	1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery	anytime from injection out to 12 months
Secondary	Anatomic changes	ultrasound evidence of progression to a full thickness tear	3 months and 12 months post injection