Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170312
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : November 1, 2012
Arthrex, Inc.
Information provided by (Responsible Party):
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(ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets.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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Biological: Autologous conditioned plasma (ACP) Other: Normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study
Study Start Date : September 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Autologous conditioned plasma Biological: Autologous conditioned plasma (ACP)
ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
Other Name: Platelet rich plasma
Placebo Comparator: Normal saline Other: Normal saline
Normal saline injection

Primary Outcome Measures :
  1. Pain score [ Time Frame: 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 :
  1. Physical function [ Time Frame: 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.

  2. Revision surgery [ Time Frame: Up to and including 6 weeks ]
  3. Health utility [ Time Frame: 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.

  4. Adverse events [ Time Frame: Up to and including 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01170312

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8L8E7
Hamilton General Hospital
Hamilton, Ontario, Canada
McMaster Hospital
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Arthrex, Inc.
Principal Investigator: Mohit Bhandari, MD, MSc, PhD, FRCSC McMaster University