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Comparison of Three Surgical Techniques to Achieve Patella Symmetry During Resection

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Mayo Clinic

Status

Completed

Conditions

Injuries, Knee
Arthroplasty, Replacement, Knee

Treatments

Procedure: Four Quadrant Technique
Procedure: Cutting Guide Technique
Procedure: Haptic Feedback Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT01822574
12-008219

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Cutting Guide Technique
Active Comparator group
Description:
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.
Treatment:
Procedure: Cutting Guide Technique
Haptic Feedback Technique
Active Comparator group
Description:
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.
Treatment:
Procedure: Haptic Feedback Technique
Four Quadrant Technique
Active Comparator group
Description:
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.
Treatment:
Procedure: Four Quadrant Technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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