Knee OsteoarthritisNCT03290170
Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement
A study testing Measured Resection and Gap Balancing in people with Knee Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthroplasty
- What is being tested?
- Measured Resection and Gap Balancing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2017to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- Primary, unilateral total knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
About this study
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.
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Being tested
- Measured Resection, Gap Balancing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measured ResectionProcedure or surgery
Bony landmarks are used to set femoral component rotation.
Gap BalancingProcedure or surgery
Relies on ligament releases prior to bone cuts.
| Study group | Role | What they receive |
|---|---|---|
| Measured resection technique | Experimental | Measured resection surgical technique Receives: Procedure: Measured Resection |
| Gap Balancing Technique | Experimental | Gap Balancing surgical technique Receives: Procedure: Gap Balancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant migration
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
Measured: 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
Measured: 3 and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start20 Dec 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Naudie, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Douglas Naudie, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290170
- Sponsor's protocol ID
- 109512
- Status last verified
- Apr 2019
- First submitted
- 19 Sep 2017
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Broberg JS, Naudie DDR, Howard JL, Lanting BA, Vasarhelyi EM, Teeter MG. Effect of Surgical Technique, Implant Design, and Time of Examination on Contact Kinematics: A Study of Bicruciate-Stabilized and Posterior-Stabilized Total Knee Arthroplasty. J Arthroplasty. 2024 Aug;39(8):2111-2115. doi: 10.1016/j.arth.2024.03.040. Epub 2024 Mar 22.
PubMed 38522799
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiostereometric Analysis of Gap Balancing Versus Measured Resection for the Journey II Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03290170
- Acronym / sponsor ID
- 109512
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measured resection technique | Experimental | Procedure: Measured ResectionMeasured resection surgical technique |
| Gap Balancing Technique | Experimental | Procedure: Gap BalancingGap Balancing surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18 years
- Primary, unilateral total knee arthroplasty
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measured ResectionBony landmarks are used to set femoral component rotation. | Procedure or surgery | Measured resection technique |
| Gap BalancingRelies on ligament releases prior to bone cuts. | Procedure or surgery | Gap Balancing Technique |
Primary outcome
Implant migration
Time frame: 2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively
Comparison of the two surgical techniques using radiostereometric analysis (RSA) imaging
1 secondary outcome
Contact Kinematics Under Dynamic Conditions
Time frame: 3 and 12 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Derived from this study: PubMed 38522799Broberg JS, Naudie DDR, Howard JL, Lanting BA, Vasarhelyi EM, Teeter MG. Effect of Surgical Technique, Implant Design, and Time of Examination on Contact Kinematics: A Study of Bicruciate-Stabilized and Posterior-Stabilized Total Knee Arthroplasty. J Arthroplasty. 2024 Aug;39(8):2111-2115. doi: 10.1016/j.arth.2024.03.040. Epub 2024 Mar 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Naudie, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measured Resection and Gap Balancing in people with Knee Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant migration (time frame: 2 and 6 weeks, 3, 6 and 12 months and 2 years post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.