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

The University of Western Australia

Status and phase: Unknown; Phase 3

Conditions: Supraspinatus Tear

Treatments: Other: Autologous conditioned plasma (ACP); Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01414764

11/75

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Autologous conditioned plasma (ACP)

Active Comparator group

Description:

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)

Treatment:

Other: Autologous conditioned plasma (ACP)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo