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

March 9, 2016 updated by: Brent Lanting, Lawson Health Research Institute
The purpose of this study is to examine the impact of two surgical techniques on the outcome of the knee replacement surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Gap balanced surgical technique
Gap balanced surgical technique
Active Comparator: Measured resection surgical technique
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.
Procedure: Measured resection
Measured resection surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective will be to assess coronal balance through a range of motion.
Time Frame: One year post-operatively
Assessed through dynamic fluoroscopic analysis.
One year post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patellofemoral tracking
Time Frame: One year post-operatively
Assessed using dynamic fluoroscopy.
One year post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Brent Lanting, MD., London Health Sciences Centre - University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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