Study Stopped
Comparator sawblade no longer available
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFebruary 6, 2018
February 1, 2018
Same day
January 17, 2013
February 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Implant migration
Implant migration assessed with RSA
2 years
Secondary Outcomes (1)
Economics
1 year
Study Arms (2)
New saw blade
ACTIVE COMPARATORNew saw blade
Reprocessed saw blade
ACTIVE COMPARATORReprocessed saw blade
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
You may not qualify if:
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Lateral or medial collateral ligament instability (\> 10° varus/valgus)
- Leg length discrepancy greater than 10 mm
- Bone quality precluding uncemented fixation
- Pregnancy
- Active or prior infection
- Morbid Obesity (BMI \> 40)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glen Richardsonlead
Study Sites (1)
Capital District Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glen Richardson, MD
Capital Health, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD FRCPC
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
February 1, 2015
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
February 6, 2018
Record last verified: 2018-02