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Clinical Trials/NCT01822574
NCT01822574
Completed
Not Applicable

Effect of Surgical Technique on Resection Symmetry of the Patella in Total Knee Arthroplasty

Mayo Clinic1 site in 1 country90 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Knee
Sponsor
Mayo Clinic
Enrollment
90
Locations
1
Primary Endpoint
Mean Asymmetry of the Patella After Patella Resection
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This research was performed to determine which of the three techniques used by knee surgeons at the Mayo Clinic was the most accurate at the surgical removal (resection) of the knee-cap (patella) in a symmetric fashion during total knee replacement (arthroplasty). Although all three techniques are known to be effective, the three techniques had never been compared to one another to determine if one was more effective than the others at resecting the patella.

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert T. Trousdale

MD

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The Difference Between Surgeon Goal and Actual Resection Height(Time 0 (prior to patella resection), and after surgery (approximately 3 hours))
  • Time to Complete Patella Resurfacing(Time 0 (prior to patella resection), and after surgery (approximately 3 hours))

Study Sites (1)

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