Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
New saw blade
Reprocessed saw blade
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Capital District Health Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
New saw blade
Reprocessed saw blade
Arm Description
New saw blade
Reprocessed saw blade
Outcomes
Primary Outcome Measures
Implant migration
Implant migration assessed with RSA
Secondary Outcome Measures
Economics
Cost comparison of saw blades
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01772589
Brief Title
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
Official Title
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Comparator sawblade no longer available
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Glen Richardson
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New saw blade
Arm Type
Active Comparator
Arm Description
New saw blade
Arm Title
Reprocessed saw blade
Arm Type
Active Comparator
Arm Description
Reprocessed saw blade
Intervention Type
Procedure
Intervention Name(s)
New saw blade
Intervention Type
Procedure
Intervention Name(s)
Reprocessed saw blade
Primary Outcome Measure Information:
Title
Implant migration
Description
Implant migration assessed with RSA
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Economics
Description
Cost comparison of saw blades
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic osteoarthritis of the knee indicating surgical intervention
Between the ages of 21 and 80 inclusive
Ability to give informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Richardson, MD
Organizational Affiliation
Capital Health, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
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