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Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montri D. Wongworawat, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01123889
First received: April 20, 2010
Last updated: December 24, 2013
Last verified: December 2013
Results First Received: October 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Subacromial Impingement Syndrome
Partial Thickness Rotator Cuff Tear
Interventions: Biological: platelet rich plasma injection
Drug: corticosteroid injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control

corticosteroid injection into subacromial space

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.

Experimental

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

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.


Participant Flow:   Overall Study
    Control     Experimental  
STARTED     5     7  
COMPLETED     2     6  
NOT COMPLETED     3     1  
Lost to Follow-up                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Control

corticosteroid injection into subacromial space

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.

Experimental

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

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.

Total Total of all reporting groups

Baseline Measures
    Control     Experimental     Total  
Number of Participants  
[units: participants]
  5     7     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     6     10  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 6.4     59.3  ± 14.7     59.25  ± 11.54  
Gender  
[units: participants]
     
Female     1     3     4  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
United States     5     7     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain and Disability of the Shoulder Through Validated Questionnaires   [ Time Frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma ]

2.  Primary:   Pain and Disability of the Shoulder Through Validated Questionnaires   [ Time Frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma ]

3.  Primary:   Pain and Disability of the Shoulder Through Validated Questionnaires   [ Time Frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Liz Clarke
Organization: Loma Linda University Orthopaedic Surgery
phone: 909-558-5592
e-mail: eaclarke@llu.edu


Publications:

Responsible Party: Montri D. Wongworawat, Loma Linda University
ClinicalTrials.gov Identifier: NCT01123889     History of Changes
Other Study ID Numbers: 59322
Study First Received: April 20, 2010
Results First Received: October 31, 2013
Last Updated: December 24, 2013
Health Authority: United States: Food and Drug Administration