Treatment of Rotator Cuff Tears With Platelet Rich Plasma
- Conditions
- Rotator Cuff TendinitisRotator Cuff Tears
- Interventions
- Biological: Platelet Rich Plasma (PRP)
- Registration Number
- NCT06481046
- Lead Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group Platelet Rich Plasma (PRP) 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.
- Primary Outcome Measures
Name Time Method Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) change from baseline to 24 months 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.
- Secondary Outcome Measures
Name Time Method Visual Analog Scale (VAS) for pain change from baseline to 24 months 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.
Global Improvement change from baseline to 24 months Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved.
Trial Locations
- Locations (1)
Illinois Sportsmedicine and Orthopaedic Centers
🇺🇸Glenview, Illinois, United States
Illinois Sportsmedicine and Orthopaedic Centers🇺🇸Glenview, Illinois, United States