Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01170312
First received: July 22, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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(ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets.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 Intervention
Rotator Cuff Tear
Biological: Autologous conditioned plasma (ACP)
Other: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Pain score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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:
  • Physical function [ Time Frame: Up to and including 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Revision surgery [ Time Frame: Up to and including 6 weeks ] [ Designated as safety issue: Yes ]
  • Health utility [ Time Frame: Up to and including 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to and including 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170312

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