Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Biological: Autologous conditioned plasma (ACP); Other: Normal saline

• Registration Number: NCT01170312
• Lead Sponsor: McMaster University

Brief Summary

Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of less pain and better function after their surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets. Platelets release growth factors important for healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has been shown to accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff tears. It is on this basis that the study is being performed. Participating patients will receive either a PRP injection or a placebo (normal saline) and the effects will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires. The primary hypothesis for this study is that ACP compared with placebo is effective in reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week pain scores compared to the placebo group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2010-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Men or women who are between 18 and 70 years of age.
• Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.
• Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.
• Provision of informed consent.

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Exclusion Criteria

• Rotator cuff tears secondary to a fracture.
• Patients with an associated dislocation at the time of randomization.
• Rotator cuff tears that underwent prior surgical repair or revision arthroscopy.
• Non-surgical rotator cuff associated treatment in the 1 month prior to randomization including corticosteroid injection and anti-inflammatory treatment.
• Prior platelet rich plasma injection.
• Pre-existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology, local malignancy, and systemic disorders (e.g., uncontrolled diabetes, hypothyroidism).
• Patients with gross shoulder instability.
• Patients with an active infection.
• Patients who are pregnant or plan to become pregnant in the next 12 months.
• Patients with a pre-operative platelet count less than 125,000 and a pre-operative hemoglobin of 7.5g/dl or less.
• Likely problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
• Patients who do not read and speak English.
• Patients participating in another ongoing trial that would interfere with the assessment of the primary or secondary outcomes.
• Any other reason (in the judgment of the surgeon).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous conditioned plasma	Autologous conditioned plasma (ACP)	-
Normal saline	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Pain score	6 weeks	To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks.; Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine.

Secondary Outcome Measures

Name	Time	Method
Revision surgery	Up to and including 6 weeks
Physical function	Up to and including 6 weeks	As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
Health utility	Up to and including 6 weeks	As measured by the EuroQol-5 Dimensions (EQ-5D) administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
Adverse events	Up to and including 6 weeks

Trial Locations

Locations (3)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

McMaster Hospital; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada