CClinicalTrials.gg
Status unknownNCT03290170Updated Apr 29, 2019

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

An interventional study of Measured Resection and Gap Balancing in Knee Osteoarthritis and Knee Arthroplasty, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Knee Arthroplasty
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Measured resection technique

    Measured resection surgical technique

    Procedure: Measured Resection

  • Experimental
    Gap Balancing Technique

    Gap Balancing surgical technique

    Procedure: Gap Balancing

Interventions

  • ProcedureMeasured Resection

    Bony landmarks are used to set femoral component rotation.

  • ProcedureGap Balancing

    Relies on ligament releases prior to bone cuts.

05

What researchers measure

Primary outcomes

  1. Implant migration

    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 outcomes

  1. Contact Kinematics Under Dynamic Conditions

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

    Time frame: 3 and 12 months post-operatively

Other outcomes

  1. Patient-reported outcomes (PROs)

    Comparison of the two surgical techniques using PROs

    Time frame: 2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively

06

Study locations

1 site
  • London Health Sciences Centre - University Hospital
    London, Ontario N6A5A5, Canada
07

Registry details

Key details

Study ID
NCT03290170
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Douglas Naudie (Orthopaedic Surgeon, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Sep 21, 2017
Start date
Dec 20, 2017
Primary completion
Aug 31, 2019 (estimated)
Completion
Aug 31, 2019 (estimated)
Last update
Apr 29, 2019

Study contacts

Douglas Naudie, MD
principal investigator · London Health Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion