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Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

This study has been withdrawn prior to enrollment.
(Comparator sawblade no longer available)
Information provided by (Responsible Party):
Glen Richardson, Capital District Health Authority, Canada Identifier:
First received: January 17, 2013
Last updated: February 17, 2015
Last verified: February 2015

There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health.

Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.

Condition Intervention
Osteoarthritis Procedure: New saw blade Procedure: Reprocessed saw blade

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Official Title: Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis

Resource links provided by NLM:

Further study details as provided by Glen Richardson, Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Implant migration [ Time Frame: 2 years ]
    Implant migration assessed with RSA

Secondary Outcome Measures:
  • Economics [ Time Frame: 1 year ]
    Cost comparison of saw blades

Enrollment: 0
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: New saw blade
New saw blade
Procedure: New saw blade
Active Comparator: Reprocessed saw blade
Reprocessed saw blade
Procedure: Reprocessed saw blade


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Symptomatic osteoarthritis of the knee indicating surgical intervention
  2. Between the ages of 21 and 80 inclusive
  3. Ability to give informed consent

Exclusion Criteria:

  1. Significant co-morbidity affecting ability to ambulate
  2. Flexion contracture greater than 15°
  3. Extension lag greater than 10°
  4. Tibial subluxation greater than 10 mm on standing AP radiograph
  5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
  6. Lateral or medial collateral ligament instability (> 10° varus/valgus)
  7. Leg length discrepancy greater than 10 mm
  8. Bone quality precluding uncemented fixation
  9. Pregnancy
  10. Active or prior infection
  11. Morbid Obesity (BMI > 40)
  12. Medical condition precluding major surgery
  13. Severe osteoporosis or osteopenia
  14. Neuromuscular impairment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01772589

Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Glen Richardson
Principal Investigator: Glen Richardson, MD Capital Health, Canada
  More Information

Responsible Party: Glen Richardson, MD FRCPC, Capital District Health Authority, Canada Identifier: NCT01772589     History of Changes
Other Study ID Numbers: SAW BLD
Study First Received: January 17, 2013
Last Updated: February 17, 2015

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 16, 2017