NCT01414764|UnknownPhase 3DMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning within two weeks of surgery, can improve patient outcomes over the course of 12 months. These outcomes will be measured by post-surgical pain and function scores, shoulder strength and range of motion (ROM), and radiological parameters of tendon healing. Outcome measures will be compared to a control group of patients receiving placebo injections following surgery (saline plus local anaesthetic). This study is significant for being the first double blind randomised control trial, using two PRP injections to examine the efficacy of a PRP preparation following surgical repair of supraspinatus tendon. The objective is to prolong and enhance the tendon healing response initiated by surgery. The research hypothesis is that enhanced tendon healing following the PRP injections will lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon compared to the control group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 23, 2011
Actual (reported)August 11, 2011
Actual (reported)January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in magnetic resonance imaging (MRI) score over time
MRI will assess the dimensions of the supraspinatus tear pre-operatively. MRI will assess the tendon healing of the supraspinatus tendon post-operatively at 12 months
Pre-operatively, and 12 months post-operatively
Changes in shoulder range of motion over time
pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in strength of the shoulder musculature over time
6 months post-operatively, 12 months post-operatively
Changes in the visual analogue scale (VAS) for pain over time
Pre-operatively, 1st injection post-operatively, 2nd injection post-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Oxford Shoulder Score (OSS) over time
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The red blood cells will be discarded, and the supernatant containing ACP (with additional CaCl to activate the ACP and local anaesthetic) is injected into the tendon bone junction and adjacent area under ultrasound guidance. No adverse consequences are anticipated by using the Arthrex ACP injection. * First injection at approximately 10 days post-operatively * Second Injection at approximately 21 days post-operatively Other Names: Platelet rich plasma (PRP)
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound. * First injection at approximately 10 days post-operatively * Second Injection at approximately 21 days post-operatively
10ml of patient's own venous blood is aspirated. ACP (1ml) (extracted from centrifuged venous sample), with additional calcium chloride is then injected into the tendon-bone junction and adjacent area under guided ultrasound. * First injection at approximately 10 days post-operatively * Second Injection at approximately 21 days post-operatively
Fremantle Hospital Radiology Department
Fremantle, Western Australia, 6160, Australia
Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.
Allan Wang, FRACS PhD
The University of Western Australia
Timothy Ackland, BSc PhD
The University of Western Australia
First Submitted
June 23, 2011
First Posted
August 11, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Platelet Rich Plasma and Supraspinatus Tear
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (1ml saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound. * First injection at approximately 10 days post-operatively * Second Injection at approximately 21 days post-operatively
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January 2015
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 9, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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