Treatment of Rotator Cuff Tears With Platelet Rich Plasma

The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Study Overview

• Status: Withdrawn
• Conditions: Rotator Cuff Tears; Rotator Cuff Tendinitis
• Intervention / Treatment: Biological: Platelet Rich Plasma (PRP)

Detailed Description

Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Glenview, Illinois, United States, 60025
      • Illinois Sportsmedicine and Orthopaedic Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Rotator cuff pathology established by exam
• Rotator cuff pathology confirmed with MRI.
• Failure to improve with activity modification and physical therapy
• Willingness to stop all NSAID medication

Exclusion Criteria:

• Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
• Shoulder surgery within 6 months.
• Presence of full thickness rotator cuff tears in patients amenable to surgical repair.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group; Dual injections of PRP - 4 ml injected into each location. The first injection was into the supraspinatus tendon insertion critical zone and bursal area with the patient seated. The second injection was performed with the patient prone into the glenohumeral intra-articular space under the supraspinatus tendon at, or just proximal to, the superior equator of the humeral head.

Biological: Platelet Rich Plasma (PRP); Platelet Rich Plasma (PRP) prepared from patient blood, spun twice to concentrate platelets. 45 cc of initial blood resulting in 4cc of injectable PRP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)	Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.	change from baseline to 6 months
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)	Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.	change from baseline to 12 months
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)	Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.	change from baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for pain	The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.	change from baseline to 6 months
Visual Analog Scale (VAS) for pain	The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.	change from baseline to 12 months
Visual Analog Scale (VAS) for pain	The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain.	change from baseline to 24 months
Global Improvement	Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.	change from baseline to 6 months
Global Improvement	Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.	change from baseline to 12 months
Global Improvement	Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.	change from baseline to 24 months

Collaborators and Investigators

• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
• Investigators: Principal Investigator: Chadwick Prodromos, MD, Illinois Sportsmedicine and Orthopaedic Centers

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2015
• Primary Completion (Actual): January 25, 2015
• Study Completion (Actual): January 25, 2015

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: 2015RC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No