- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822574
Comparison of Three Surgical Techniques to Achieve Patella Symmetry During Resection
Effect of Surgical Technique on Resection Symmetry of the Patella in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Resection of the patella to prepare it for placement of a patellar prosthesis is a procedure that is performed routinely in the vast majority of total knee arthroplasties (TKA) in the United States and at the Mayo Clinic. This procedure is performed by a number of different techniques that have been proved to be safe and effective. Despite this, patellar instability, tilt, obliquity, and maltracking are all possible complications of improperly resected patellae during TKA. The goals of resection are to create a patella that is symmetrical, absent of obliquity (slanting), and thick enough to receive a patellar prosthesis. Although outcomes are generally good for most described methods, to date, little had been published regarding direct comparison of these methods.
Patients undergoing TKA with planned patellar resection were randomized to have their patella resected by one of three methods during primary TKA: 1) use of a cutting guide, 2) haptic feedback, or 3) free-hand resection guided by four quadrant measurements. There were three experienced fellowship-trained arthroplasty surgeons (hip and knee) performing the procedures who were all familiar and experienced with each of the three techniques being investigated. Each surgeon, within a group of 30 of their patients, performed a total 10 resections using each of the three methods listed above (30 resections per surgeon for a total of 90 resections).
Before and after resection measurements of knee-cap thickness were taken and used to determine patellar symmetry. The resulting symmetry of each of the three techniques was then be compared between and within each of the three techniques and surgeons. Each procedure was also be timed from first measurement by the staff surgeon to the final measurement by that surgeon.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients scheduled for primary total knee arthroplasty with planned patellar resection by one of the three staff surgeons included in the study.
- Patient must be able and willing to provide consent for study participation
Exclusion Criteria:
- Patient in need of revision total knee arthroplasty or having already undergone prior total knee arthroplasty
- Patient not in need of patellar resection during their primary total knee arthroplasty
- Unwilling or unable to provide consent for participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cutting Guide Technique
The guide is clamped onto the patella and tightened so that it remains stable.
The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella.
The thickness is then measured in the center of the patella to ensure that the resection goal is achieved.
Additional resection may be performed as needed.
|
The guide is clamped onto the patella and tightened so that it remains stable.
The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella.
The thickness is then measured in the center of the patella to ensure that the resection goal is achieved.
Additional resection may be performed as needed.
|
Active Comparator: Haptic Feedback Technique
It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon.
The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella.
The thickness is then measured in the center of the patella to ensure that the resection goal is achieved.
Additional resection may be performed as needed.
|
It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon.
The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella.
The thickness is then measured in the center of the patella to ensure that the resection goal is achieved.
Additional resection may be performed as needed.
|
Active Comparator: Four Quadrant Technique
Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral).
Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
|
Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral).
Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Asymmetry of the Patella After Patella Resection
Time Frame: approximate average surgery time of 3 hours
|
Post-resection symmetry of the patella was independently assessed by a resident or fellow who was not involved in the resection.
This was evaluated by dividing the patella into four equal quadrants and measuring the thickness in the center of each quadrant using a ring tipped or "C"-shaped caliper.
The difference between the thickest and thinnest measurements of the patella was reported as the value of asymmetry.
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approximate average surgery time of 3 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Difference Between Surgeon Goal and Actual Resection Height
Time Frame: Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
|
This outcome measure attempts to capture the most accurate method for obtaining a desired thickness.
Each patellar resection procedure began by exposing the articular surface of the patella.
Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started.
The surgeon then stated their goal for post resection thickness, and these values were recorded.
After the final resection, the timer was stopped.
The ability to obtain the resection goal was independently assessed by a resident or fellow not involved in the resection.
This was calculated by taking the difference between the surgeon's goal and the average thickness of the four quadrants measured by the resident or fellow.
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Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
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Time to Complete Patella Resurfacing
Time Frame: Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
|
Each patellar resection procedure began by exposing the articular surface of the patella.
Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started.
After the final resection, the timer was stopped.
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Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Trousdale, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-008219
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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