Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?

PHASE3UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

January 31, 2015

Study Completion Date

February 28, 2015

Conditions
Supraspinatus Tear
Interventions
OTHER

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"

DRUG

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"

Trial Locations (1)

6160

Fremantle Hospital Radiology Department, Fremantle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arthrex, Inc.

INDUSTRY

lead

The University of Western Australia

OTHER