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

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gap balanced surgical technique
Measured resection
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total knee replacement, Gap balanced, Measured resection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gap balanced surgical technique

Measured resection surgical technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary objective will be to assess coronal balance through a range of motion.
Assessed through dynamic fluoroscopic analysis.

Secondary Outcome Measures

Patellofemoral tracking
Assessed using dynamic fluoroscopy.

Full Information

First Posted
May 14, 2013
Last Updated
March 9, 2016
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01855906
Brief Title
The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
Official Title
The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total knee replacement, Gap balanced, Measured resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gap balanced surgical technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Measured resection surgical technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gap balanced surgical technique
Intervention Description
Gap balanced surgical technique
Intervention Type
Procedure
Intervention Name(s)
Measured resection
Intervention Description
Measured resection surgical technique
Primary Outcome Measure Information:
Title
The primary objective will be to assess coronal balance through a range of motion.
Description
Assessed through dynamic fluoroscopic analysis.
Time Frame
One year post-operatively
Secondary Outcome Measure Information:
Title
Patellofemoral tracking
Description
Assessed using dynamic fluoroscopy.
Time Frame
One year post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Lanting, MD.
Organizational Affiliation
London Health Sciences Centre - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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