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

NCT01414764 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-09

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • The University of Western Australia

    lead OTHER

Principal Investigators

  • Allan Wang, FRACS PhD · The University of Western Australia

  • Timothy Ackland, BSc PhD · The University of Western Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414764 on ClinicalTrials.gov