Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

Study Overview
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Brief Summary
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The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.

Official Title
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Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma

Conditions
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Subacromial Impingement Syndrome, Partial Thickness Rotator Cuff Tear

Intervention / Treatment
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* Biological: platelet rich plasma injection
* Drug: corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with rotator cuff symptoms for at least 4 weeks Examination reveals diffuse pain with provocative maneuvers Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear) Willingness to participate in an investigational technique Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week) Exclusion Criteria: Previous rotator cuff repair Complete rotator cuff tear or two tendon tears Pt w/ complex regional pain syndrome Cervical neuropathy or other nerve pathology RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy Evidence of intraarticular arthritis Work related or compensable injury Previous treatment: corticosteroid injection in the last 6 months Patients who are currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>corticosteroid injection into subacromial space | Drug: corticosteroid injection<br>* Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.<br>* Other names: xylocaine;|
| Experimental: experimental<br>patients will receive an injection of platelet rich plasma into the subacromial space | Biological: platelet rich plasma injection<br>* 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.<br>* Other names: xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 6 weeks from initial injection of corticosteroid versus platelet rich plasma | 
| Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 12 weeks from initial injection of corticosteroid versus platelet rich plasma | 
| Pain and Disability of the Shoulder Through Validated Questionnaires | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. | 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma