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

Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Supraspinatus Tear
• Intervention / Treatment: Other: Autologous conditioned plasma (ACP); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Hospital Radiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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; Other Names: Platelet rich plasma (PRP)
Placebo Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in shoulder range of motion over time	Shoulder range of motion measures will include: internal humeral rotation of the affected arm; external humeral rotation of the affected arm; forward flexion of the affected arm; abduction of the affected arm	pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in strength of the shoulder musculature over time	Muscular strength will be measured through: internal humeral rotation of the affected arm; external humeral rotation of the affected arm; forward flexion of the affected arm; abduction of the affected arm	6 months post-operatively, 12 months post-operatively
Changes in the visual analogue scale (VAS) for pain over time	The VAS is a scale from 1 to 10 and requires the patient to rate their pain along the scale; with 0 equating to no pain and 10 equating to the worst possible pain.	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	The QuickDASH is a shortened version of the Disabilities of the Arm Shoulder and Hand (DASH) outcome measure. It uses 11 items instead of the original 30 items to measure physical function and symptoms in persons with any or multiple musculoskeletal disorders of the upper arm.	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	The OSS is a self-reported questionnaire developed to evaluate disability in those with injuries and impairment of the rotator cuff.	Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Simple Shoulder Test (SST) over time	The SST consists of a series of 12 "yes" or "no" questions regarding function of the involved shoulder.	Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Short Form - 12 health questionnaire (SF-12) over time	The SF-12 is a shortened version of the Short Form-36 (SF-36). It uses 12 items instead of 36, to measure general functional health and well-being from the patient's point of view.	Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively

Collaborators and Investigators

• Sponsor: The University of Western Australia
• Collaborators: Arthrex, Inc.
• Investigators: Principal Investigator: Allan Wang, FRACS PhD, The University of Western Australia; Study Chair: Timothy Ackland, BSc PhD, The University of Western Australia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 7, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: rotator cuff tendon repair surgery; supraspinatus tendon repair
• Other Study ID Numbers: 11/75