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Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement

Primary Purpose

Knee Osteoarthritis, Knee Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Measured Resection
Gap Balancing
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Over the age of 18 years
  • Primary, unilateral total knee arthroplasty

Exclusion Criteria:

  • History of alcoholism
  • Inability to speak or read English (questionnaires are only provided in English)
  • Pregnant women and women with plans to begin a family
  • Inflammatory arthritis -Bilateral total knee arthroplasty
  • Revision total knee arthroplasty

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Measured resection technique

Gap Balancing Technique

Arm Description

Measured resection surgical technique

Gap Balancing surgical technique

Outcomes

Primary Outcome Measures

Implant migration
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging

Secondary Outcome Measures

Contact Kinematics Under Dynamic Conditions
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging

Full Information

First Posted
September 19, 2017
Last Updated
April 26, 2019
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03290170
Brief Title
Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement
Official Title
Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized study comparing the measured resection and gap-balancing surgical techniques for total knee replacement (TKR) using a cemented Journey II TKR implant system. We will be comparing the two surgical methods by evaluating implant migration using radiostereometric analysis (RSA) imaging, evaluating contact kinematics (knee mechanics) through RSA under dynamic conditions and comparing patient knee outcome scores.
Detailed Description
The stability of a total knee replacement (TKR) surgery depends on soft tissue balance (i.e. balance of supporting ligaments) and bony cuts made during surgery that dictate the rotation of the femoral (thigh bone) component. Two main techniques predominate for execution of the bone cuts and soft tissue balance in TKR. In measured resection, pre-determined bony cuts are made and appropriate balance is obtained by judicious soft tissue releases as required. In gap balancing, the bony cuts for femoral rotation are driven by the native soft tissues. How these two surgical approaches affects the biomechanics of the knee invivo is unclear. The purpose of this study is to examine the patello-femoral articulation as well as coronal balance of the respective techniques under dynamic conditions. Secondary goals will be to examine the impact on femoral component position on changes to coronal plane position through a range of flexion/extension. As patellofemoral symptoms and flexion instability are two of the most common causes of patient dissatisfaction and revision in the short term, this study has the potential to have significant patient impact. The study also has the potential to provide information on long term wear potential if articular incongruity is found. TKA is a procedure that has good results in most patients, however, up to 20% of patients are not satisfied with their outcome. (1) Some of these dissatisfied patients require early revision. Early revisions are often attributed to technical issues, such as revisions required for instability, patellofemoral symptoms, stiffness or aseptic loosening (2). This highlights the impact of surgical technique on clinical outcomes. There are two main philosophies on how to complete bone resections and achieve a balanced TKA. The measured resection technique utilizes a standard set of bony cuts based on bony landmarks and then balances the knee by making judicious soft tissue releases. Component position, particularly femoral rotation, is fairly constant with using this technique. Gap balancing adjusts the bony cuts for femoral rotation to balance the soft tissues of the knee in flexion, potentially avoiding the necessity of soft tissue releases. In contrast to the measured resection technique, gap balancing allows for variable rotation of the femoral component. This variability in femoral rotation has the potential to impacts the coronal plane motion as well as tracking at the patellofemoral articulation. Surgeons have strong opinions that both the gap balanced (3) and measured resection techniques (4) provide superior results. However, in spite of a variety of literature in support of each technique, little has been done to compare the biomechanics of each technique. There is a lack of scientifically rigorous assessment of the impact of surgical technique on femoral rotation, with resultant changes to coronal plane motion. This prevents the elucidation of potential sources of clinical outcome differences both in the short term and the long term. The impact of femoral component rotation will be examined by examining the coronal plane motion. An area impacted by the two TKA techniques is how they impact coronal plane motion in flexion. There has only been one paper written utilizing dynamic fluoroscopy to examine the differences in techniques (7). This study examined lift-off of the lateral component in a comparative study of the two techniques using dynamic fluoroscopy. This study was limited in nature, with only the ability to quantify the amount of separation of the femoral component from the tibial component in flexion. It did not examine the impact of femoral rotation on flexion alignment, or correlate patient satisfaction scores to the dynamic fluoroscopy findings. With the combination of advanced imaging to determine component position with respect to bony landmarks (8) as well as dynamic fluoroscopy, a large area of new information can be gathered. Examination of the impact of surgical technique with the use of cement to femoral component rotation, and how this impacts coronal plane motion are achievable goals, with potential for a significant impact on patient outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Measured resection technique
Arm Type
Experimental
Arm Description
Measured resection surgical technique
Arm Title
Gap Balancing Technique
Arm Type
Experimental
Arm Description
Gap Balancing surgical technique
Intervention Type
Procedure
Intervention Name(s)
Measured Resection
Intervention Description
Bony landmarks are used to set femoral component rotation.
Intervention Type
Procedure
Intervention Name(s)
Gap Balancing
Intervention Description
Relies on ligament releases prior to bone cuts.
Primary Outcome Measure Information:
Title
Implant migration
Description
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
Time Frame
2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively
Secondary Outcome Measure Information:
Title
Contact Kinematics Under Dynamic Conditions
Description
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
Time Frame
3 and 12 months post-operatively
Other Pre-specified Outcome Measures:
Title
Patient-reported outcomes (PROs)
Description
Comparison of the two surgical techniques using PROs
Time Frame
2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 18 years Primary, unilateral total knee arthroplasty Exclusion Criteria: History of alcoholism Inability to speak or read English (questionnaires are only provided in English) Pregnant women and women with plans to begin a family Inflammatory arthritis -Bilateral total knee arthroplasty Revision total knee arthroplasty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Naudie, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

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Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement

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