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

Supraspinatus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01414764
• Other study ID #: 11/75
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: June 23, 2011
• Last updated: December 7, 2014
• Start date: May 2011
• Est. completion date: February 2015

Study information

• Verified date: December 2014
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supraspinatus Tear

Intervention

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

Locations

Country	Name	City	State
Australia	Fremantle Hospital Radiology Department	Fremantle	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The University of Western Australia	Arthrex, Inc.

Country where clinical trial is conducted

Australia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No