Comparison of Three Surgical Techniques to Achieve Patella Symmetry During Resection

NCT01822574 | Completed Results

• 1 other identifier: 12-008219
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Injuries, Knee

Outcome Measures

Primary Outcomes (1)

• Mean Asymmetry of the Patella After Patella Resection

  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.

  approximate average surgery time of 3 hours

Secondary Outcomes (2)

• 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 Arms (3)

Cutting Guide Technique

ACTIVE COMPARATOR

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.

Procedure: Cutting Guide Technique

Haptic Feedback Technique

ACTIVE COMPARATOR

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.

Procedure: Haptic Feedback Technique

Four Quadrant Technique

ACTIVE COMPARATOR

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.

Procedure: Four Quadrant Technique

Interventions

Cutting Guide Technique PROCEDURE

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.

Cutting Guide Technique

Haptic Feedback Technique PROCEDURE

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.

Haptic Feedback Technique

Four Quadrant Technique PROCEDURE

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.

Four Quadrant Technique

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 26115983 RESULT

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Robert T. Trousdale, M.D.
• Organization: Mayo Clinic

trousdale.robert@mayo.edu

507-284-6586

Study Officials

• Robert Trousdale, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 2, 2016
• Results First Posted: March 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)