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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772589
First Posted: January 21, 2013
Last Update Posted: February 18, 2015
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.
Information provided by (Responsible Party):
Glen Richardson, Capital District Health Authority, Canada
  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
Intervention Model: Parallel Assignment
Masking: Triple (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Glen Richardson, MD FRCPC, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01772589     History of Changes
Other Study ID Numbers: SAW BLD
First Submitted: January 17, 2013
First Posted: January 21, 2013
Last Update Posted: February 18, 2015
Last Verified: February 2015

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