Treatment of Rotator Cuff Tears With Platelet Rich Plasma

NCT ID: NCT06481046

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-23
• Study Completion Date: 2015-01-25

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.

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Tendinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet Rich Plasma (PRP)

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chadwick Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

Illinois Sportsmedicine and Orthopaedic Centers

Locations

Illinois Sportsmedicine and Orthopaedic Centers

Glenview, Illinois, United States

Countries

United States

Other Identifiers

2015RC

Identifier Type: -

Identifier Source: org_study_id