Rotator Cuff Tears, Rotator Cuff Tendinitis
Conditions
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.
Interventions
BIOLOGICALPlatelet 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.
Sponsors
The Foundation for Orthopaedics and Regenerative Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) | change from baseline to 6 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for pain | change from baseline to 6 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 6 months | Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved. |
Countries
United States
Outcome results
None listed