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Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Glen Richardson, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01772589
First received: January 17, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Implant migration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Implant migration assessed with RSA


Secondary Outcome Measures:
  • Economics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cost comparison of saw blades


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01772589

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

No publications provided

Responsible Party: Glen Richardson, MD FRCPC, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01772589     History of Changes
Other Study ID Numbers: SAW BLD
Study First Received: January 17, 2013
Last Updated: July 29, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014