The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation

Not Applicable

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Procedure: Measured resection; Procedure: Gap balanced surgical technique

• Registration Number: NCT01855906
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The purpose of this study is to examine the impact of two surgical techniques on the outcome of the knee replacement surgery.

Detailed Description

How stable a total knee replacement is depends on the correct and precise rotation of the femoral component. Abnormal femoral component rotation has been associated with numerous adverse conditions including knee instability, knee pain, scar tissue, and abnormal knee motion. Controversy exists, however, regarding the most favorable surgical technique to determine accurate femoral component rotation. Some doctors prefer a measured resection technique in which landmarks on the femur bone are used to determine where to place the femoral component. Others recommend a gap-balancing technique in which the femoral component is positioned by balancing the ligaments of the knee and placing it in the position where each ligament is equally strained.

The purpose of this study is to examine the impact of the measured resection and gap-balancing surgical technique on how the total knee replacement moves and patient knee outcome scores. Knee outcome scores are assessed from the responses given by patients to questions about outcomes associated with total knee replacement related to pain, symptoms, activities of daily living, sport and recreational function, and knee-related quality of life.

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Study Start: 2013-09
• Primary Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Surgeon and patient have determined that patient requires a primary total knee arthroplasty and agrees to participate and signs the informed consent for study.

Exclusion Criteria

• History of alcoholism
• Unable to speak English
• Inflammatory Arthritis
• Pregnant women or any woman with plans to begin a family.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Measured resection surgical technique	Measured resection	Study patients in this arm of the study will have their knee replacement done using the measured resection surgical technique. Pre-determined bony cuts are made and appropriate balance is obtained by judicious soft tissue releases as required.
Gap balanced surgical technique	Gap balanced surgical technique	Study patients in this arm of the study will have their knee replacement done using the gap balanced technique. Gap balancing adjusts the bony cuts for femoral rotation to balance the soft tissues of the knee in flexion.

Primary Outcome Measures

Name	Time	Method
The primary objective will be to assess coronal balance through a range of motion.	One year post-operatively	Assessed through dynamic fluoroscopic analysis.

Secondary Outcome Measures

Name	Time	Method
Patellofemoral tracking	One year post-operatively	Assessed using dynamic fluoroscopy.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada