Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

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.

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Detailed Description

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Conditions

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Subacromial Impingement Syndrome Partial Thickness Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

corticosteroid injection into subacromial space

Group Type ACTIVE_COMPARATOR

corticosteroid injection

Intervention Type DRUG

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.

experimental

patients will receive an injection of platelet rich plasma into the subacromial space

Group Type EXPERIMENTAL

platelet rich plasma injection

Intervention Type BIOLOGICAL

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.

Interventions

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platelet rich plasma injection

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.

Intervention Type BIOLOGICAL

corticosteroid injection

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.

Intervention Type DRUG

Other Intervention Names

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platelet rich plasma - PRP naropin xylocaine triamcinalone naropin xylocaine

Eligibility Criteria

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Inclusion Criteria

1. Patients presenting with rotator cuff symptoms for at least 4 weeks
2. Examination reveals diffuse pain with provocative maneuvers
3. Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
4. Willingness to participate in an investigational technique
5. Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)

Exclusion Criteria

1. Previous rotator cuff repair
2. Complete rotator cuff tear or two tendon tears
3. Pt w/ complex regional pain syndrome
4. Cervical neuropathy or other nerve pathology
5. RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
6. Evidence of intraarticular arthritis
7. Work related or compensable injury
8. Previous treatment: corticosteroid injection in the last 6 months
9. Patients who are currently pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No