Treatment of Rotator Cuff Tears With Platelet Rich Plasma

The Foundation for Orthopaedics and Regenerative Medicine

Status: Withdrawn

Conditions: Rotator Cuff Tendinitis; Rotator Cuff Tears

Treatments: Biological: Platelet Rich Plasma (PRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06481046

2015RC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment Group

Experimental group

Description:

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.

Treatment:

Biological: Platelet Rich Plasma (PRP)