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Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

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.
 
ClinicalTrials.gov Identifier: NCT01772589
Recruitment Status : Withdrawn (Comparator sawblade no longer available)
First Posted : January 21, 2013
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Glen Richardson, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 21, 2013
Last Update Posted Date February 6, 2018
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)		 Implant migration [ Time Frame: 2 years ]
Implant migration assessed with RSA
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)		 Economics [ Time Frame: 1 year ]
Cost comparison of saw blades
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
Official Title  ICMJE Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Procedure: New saw blade
  • Procedure: Reprocessed saw blade
Study Arms  ICMJE
  • Active Comparator: New saw blade
    New saw blade
    Intervention: Procedure: New saw blade
  • Active Comparator: Reprocessed saw blade
    Reprocessed saw blade
    Intervention: Procedure: Reprocessed saw blade
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 17, 2015)		 0
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)		 40
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772589
Other Study ID Numbers  ICMJE SAW BLD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glen Richardson, Nova Scotia Health Authority
Study Sponsor  ICMJE Glen Richardson
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glen Richardson, MD Capital Health, Canada
PRS Account Nova Scotia Health Authority
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP