- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02230215
Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.
All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith & Nephew).
Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.
• Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.
During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.
RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.
Model based RSA software used to measure motion of implant components relative to bone markers.
All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A5A5
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing primary total knee replacement surgery
- No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
- BMI < 40
- Study patients should live within 100 km of our facility to ensure availability for follow-up
Exclusion Criteria:
- Pregnancy or considering pregnancy
- BMI > 40
- Unable to undergo MRI screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient-Specific Instrumentation
Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation
|
The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
Other Names:
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No Intervention: Traditional Instrumentation
Patients to have a total knee replacement surgery done using traditional instrumentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluating the Change in Implant Fixation assessed using RSA imaging
Time Frame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
|
Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.
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2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Outcomes including Satisfaction
Time Frame: Preoperatively, 1 year, 2 year
|
Patient reported outcome measures provide important insight into how well total knee replacement performs from the patient's perspective.
We will obtain patient surveys using four common, validated outcome measures: Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 Health Survey (SF-12), and University of California, Los Angeles (UCLA) Activity Score
|
Preoperatively, 1 year, 2 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Component Alignment
Time Frame: 1 year, 2 year
|
Using standard 3 foot hip-to-ankle radiographs to determine radiographic alignment of the implant components and mechanical axis of the limb.
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1 year, 2 year
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Cost
Time Frame: Intraoperatively
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Tracking time and instruments used per procedure and waste collected.
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Intraoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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