SickKids

Orthopaedic Surgery
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Our partners

Canadian Institutes for Health Research (CIHR):
Industrial Partnership Program

The division of Orthopaedic Surgery is presently involved in an industrial partnership with DePuyAcromed-Johnson and Johnson Medical Products and Synthes Canada. Together with a CIHR Industry-Partnered Program grant, the partners funded the following trial: A Randomized Clinical Trial Comparing the Moss Miami and Universal Spinal Instrumentation Systems for Adolescent Idiopathic Scoliosis.

"The CIHR Industry-Partnered Program is designed to help the academic community interact with Canadian companies with an interest in health research and development. Successful co-funding for industry sponsored trials is granted by CIHR if the research involves humans where at least two interventions in health care are compared using random allocation, statistical methodologies and blinding techniques". If you would like more information about this program please contact CIHR.

The investigators of the trial do not receive any financial gain aside from the funding of the trial (i.e. no royalties, stock or stock options, or any other commercially derived honoraria etc). Investigators have control over all aspects of the trial including : subject eligibility, randomization, outcome assessment and data analysis. The investigators also own all data, patient records, x-rays and clinical photos.

The Trial

Idiopathic scoliosis affects 2-5% of adolescents. Approximately 10% of adolescents with severe idiopathic scoliosis will receive spinal instrumentation and fusion to prevent progression and to correct spinal deformity. Despite the frequency of this procedure and the many available spinal instrumentation systems, no studies have evaluated patients' cosmesis and function after surgery and no randomized clinical trials have compared the outcomes of spinal instrumentation systems for adolescents with idiopathic scoliosis.

The specific aims of this trial are:

  1. To compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of the Moss Miami and Universal Instrumentation Systems for the treatment of adolescent idiopathic scoliosis.
  2. To determine the relationship between the clinical and radiographic assessment of scoliosis compared with patients' perception of their scoliosis and their functional outcome.

The industrial partners have participated directly in one specific aspect of this research trial. Spine product managers and spine product sales representatives were asked to rate the cosmesis of patients with varying degrees of scoliosis (mild, moderate and severe). This will be compared to ratings done by orthopaedic surgeons, scoliosis patients, and parents of scoliosis patients.

This trial has completed subject accrual and is now in the last stage of assessing subjects for their final follow-up appointment. Although there was no interim analysis and final results will not be known for approximately 18 months, investigators have analyzed baseline data and presented results at international meetings. Abstracts have been submitted (for 2003) and accepted (for 2002) for the annual meetings of the Canadian Orthopaedic Association (COA), Canadian Spine Society (CSS), Pediatric Orthopaedic Society of North America (POSNA) and Scoliosis Research Society (SRS). The following abstracts have been submitted and industrial partners are acknowledged in the corresponding podium presentation, poster, abstract and manuscript:

  • Quality of Life in Adolescent Idiopathic Scoliosis (2002). J. Wright, S. Donaldson, D. Hedden, B. Alman,and A. Howard.
  • Surgeon Reliability in Rating Cosmesis In Adolescent Idiopathic Scoliosis (2003). S. Donaldson, J. Wright, D. Stephens, D. Hedden, B. Alman and A. Howard.
  • Patient Characteristics Associated with Surgeons' Ratings of Physical Deformity in Adolescent Idiopathic Scoliosis (2003).  S. Donaldson, D. Hedden, D. Stephens, B. Alman, A. Howard, and J. Wright
  • Concerns, Desires & Expectations of Surgery for Adolescent Idiopathic Scoliosis (AIS):  A Comparison of Patients', Parents' and Surgeons' Perspectives (2003).  U. Narayanan, J. Wright, D. Hedden, B. Alman, A. Howard, B. Feldman, M. Krahn, J. Llewellyn-Thomas, M. Slater, and S. Donaldson.

If you would like more information on industrial partnerships with the division of orthopaedic surgery, please contact: ortho.industrialpartnerships@sickkids.ca