Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01822574
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2013-03-18
Brief Title:
Comparison of Three Surgical Techniques to Achieve Patella Symmetry During Resection
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Effect of Surgical Technique on Resection Symmetry of the Patella in Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None