Clinical trial NCT01822574: Comparison of Three Surgical Techniques to Achieve Patella Symmetry During Resection
Official title: Effect of Surgical Technique on Resection Symmetry of the Patella in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Injuries, Knee
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Asymmetry of the Patella After Patella Resection
timeFrame: approximate average surgery time of 3 hours
Secondary outcomes:
measure: The Difference Between Surgeon Goal and Actual Resection Height
timeFrame: Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
measure: Time to Complete Patella Resurfacing
timeFrame: Time 0 (prior to patella resection), and after surgery (approximately 3 hours)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Trousdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camp CL, Martin JR, Krych AJ, Taunton MJ, Spencer-Gardner L, Trousdale RT. Resection Technique Does Affect Resection Symmetry and Thickness of the Patella During Total Knee Arthroplasty: A Prospective Randomized Trial. J Arthroplasty. 2015 Dec;30(12):2110-5. doi: 10.1016/j.arth.2015.05.038. Epub 2015 May 29.