Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?
NCT ID: NCT01414764
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2011-05-31
2015-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Autologous conditioned plasma (ACP)
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)
Autologous conditioned plasma (ACP)
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
Placebo
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
Placebo
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
Interventions
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Autologous conditioned plasma (ACP)
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
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In a non-dependent relationship;
* Full-thickness supraspinatus tendon tear (deemed repairable);
* Pre-operative platelet count greater than 150 000.
Exclusion Criteria
* Active/distal infection;
* Metabolic bone or blood disorders;
* Pre-existing conditions associated with upper extremity pain;
* Rotator cuff tears secondary to fracture;
* Prior ACP/PRP injections;
* Non-surgical rotator cuff treatment in the past month, including corticosteroids and anti-inflammatory treatment.
50 Years
75 Years
ALL
No
Sponsors
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Arthrex, Inc.
INDUSTRY
The University of Western Australia
OTHER
Responsible Party
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Allan Wang
Clinical Professor of Orthopaedic Surgery
Principal Investigators
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Allan Wang, FRACS PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Timothy Ackland, BSc PhD
Role: STUDY_CHAIR
The University of Western Australia
Locations
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Fremantle Hospital Radiology Department
Fremantle, Western Australia, Australia
Countries
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References
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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.
Other Identifiers
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11/75
Identifier Type: -
Identifier Source: org_study_id