Back to resultsThe Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial (PRP)
Primary Purpose
Rotator Cuff Injuries
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Platelet Rich Plasma (PRP)
Corticosteroid (CS)
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet Rich Plasma (PRP)
Corticosteroid (CS)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
visual analog scale for pain
Secondary Outcome Measures
American Shoulder and Elbow Surgeons shoulder score (ASES)
ASES score
Western Ontario Rotator Cuff Index (WORC)
WORC score
"Failure"
1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery
Anatomic changes
ultrasound evidence of progression to a full thickness tear
Full Information
NCT ID
NCT04743986
First Posted
February 3, 2021
Last Updated
February 3, 2021
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT04743986
Brief Title
The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Acronym
PRP
Official Title
The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2015 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
Keywords
corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two arm parallel randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma (PRP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Corticosteroid (CS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma (PRP)
Intervention Description
RegenLab, Lausanne, Switzerland
Intervention Type
Drug
Intervention Name(s)
Corticosteroid (CS)
Intervention Description
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
visual analog scale for pain
Time Frame
change from baseline at 6 weeks, 3 months, 12 months
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons shoulder score (ASES)
Description
ASES score
Time Frame
change from baseline at 6 weeks, 3 months, 12 months
Title
Western Ontario Rotator Cuff Index (WORC)
Description
WORC score
Time Frame
change from baseline at 6 weeks, 3 months, 12 months
Title
"Failure"
Description
1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery
Time Frame
anytime from injection out to 12 months
Title
Anatomic changes
Description
ultrasound evidence of progression to a full thickness tear
Time Frame
3 months and 12 months post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian KY Lo, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be made available.
Citations:
PubMed Identifier
33127554
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.
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The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial
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