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

NCT01414764 | Unknown Phase 3 DMC

• 1 other identifier: 11/75
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rotator cuff tendon repair surgery; supraspinatus tendon repair

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Autologous conditioned plasma (ACP)

ACTIVE COMPARATOR

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)

Other: Autologous conditioned plasma (ACP)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Autologous conditioned plasma (ACP) OTHER

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

Also known as: Platelet rich plasma (PRP)

Autologous conditioned plasma (ACP)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-75 years;
• In a non-dependent relationship;
• Full-thickness supraspinatus tendon tear (deemed repairable);
• Pre-operative platelet count greater than 150 000.

You may not qualify if:

• Previous rotator cuff repair surgery;
• 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.

Sponsors & Collaborators

• The University of Western Australia: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Fremantle Hospital Radiology Department

Fremantle, Western Australia, 6160, Australia

Location

Related Publications (1)

• 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.

  PMID: 21570659 RESULT

Study Officials

• Allan Wang, FRACS PhD

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

• Timothy Ackland, BSc PhD

  The University of Western Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: August 11, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

AU (1)