Treatment of Rotator Cuff Tears With Platelet Rich Plasma

NCT06481046 | Withdrawn

• 1 other identifier: 2015RC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Tendinitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Visual Analog Scale (VAS) for pain

  change from baseline to 6 months

• Visual Analog Scale (VAS) for pain

  change from baseline to 12 months

• Visual Analog Scale (VAS) for pain

  change from baseline to 24 months

• Global Improvement

  change from baseline to 6 months

• Global Improvement

  change from baseline to 12 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

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)

Interventions

Platelet Rich Plasma (PRP) BIOLOGICAL

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (1)

Illinois Sportsmedicine and Orthopaedic Centers

Glenview, Illinois, 60025, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Chadwick Prodromos, MD

  Illinois Sportsmedicine and Orthopaedic Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: July 1, 2024
• Study Start: January 23, 2015
• Primary Completion: January 25, 2015
• Study Completion: January 25, 2015
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)