Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT01170312|
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : November 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Biological: Autologous conditioned plasma (ACP) Other: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|Active Comparator: Autologous conditioned plasma||
Biological: Autologous conditioned plasma (ACP)
ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
Other Name: Platelet rich plasma
|Placebo Comparator: Normal saline||
Other: Normal saline
Normal saline injection
- Pain score [ Time Frame: 6 weeks ]
To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks.
Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine.
- Physical function [ Time Frame: Up to and including 6 weeks ]As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
- Revision surgery [ Time Frame: Up to and including 6 weeks ]
- Health utility [ Time Frame: Up to and including 6 weeks ]As measured by the EuroQol-5 Dimensions (EQ-5D) administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
- Adverse events [ Time Frame: Up to and including 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170312
|Hamilton, Ontario, Canada, L8L8E7|
|Hamilton General Hospital|
|Hamilton, Ontario, Canada|
|Hamilton, Ontario, Canada|
|Principal Investigator:||Mohit Bhandari, MD, MSc, PhD, FRCSC||McMaster University|