OsteoarthritisNCT02230215
Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
A study testing Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation in people with Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Aug 2018
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing primary total knee replacement surgery
- No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
- BMI < 40
- Study patients should live within 100 km of our facility to ensure availability for follow-up
Who cannot join
- Pregnancy or considering pregnancy
- BMI > 40
- Unable to undergo MRI screening
Trial locations and contacts
1 site in 1 country.
About this study
This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.
Read the detailed description
This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.
All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith \& Nephew).
Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.
- Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.
During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.
RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.
Model based RSA software used to measure motion of implant components relative to bone markers.
All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation
- Keywords
- Total Knee Replacement, Visionaire
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty with use of Visionaire Patient-Specific InstrumentationDevice
Also called Visionaire Patient Specific Instrumentation
The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific Instrumentation | Experimental | Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation Receives: Device: Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation |
| Traditional Instrumentation | No intervention | Patients to have a total knee replacement surgery done using traditional instrumentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the Change in Implant Fixation assessed using RSA imaging
Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.
Measured: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
Secondary outcomes (1)
Patient Outcomes including Satisfaction
Patient reported outcome measures provide important insight into how well total knee replacement performs from the patient's perspective. We will obtain patient surveys using four common, validated outcome measures: Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 Health Survey (SF-12), and University of California, Los Angeles (UCLA) Activity Score
Measured: Preoperatively, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionAug 2018
- Study completionAug 2018
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 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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
- Collaborators
- Canadian Orthopaedic Foundation, Smith & Nephew, Inc.
- 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
- NCT02230215
- Sponsor's protocol ID
- 105453
- Status last verified
- Nov 2018
- First submitted
- 19 Aug 2014
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02230215
- Acronym / sponsor ID
- 105453
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Replacement, Visionaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation, Smith & Nephew, Inc.
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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 study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.
Detailed description
This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.
All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith \& Nephew).
Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.
- Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.
During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.
RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.
Model based RSA software used to measure motion of implant components relative to bone markers.
All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific Instrumentation | Experimental | Device: Total Knee Arthroplasty with use of Visionaire Patient-Specific InstrumentationPatients to have a total knee replacement surgery completed using Patient-Specific Instrumentation |
| Traditional Instrumentation | No intervention | –Patients to have a total knee replacement surgery done using traditional instrumentation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing primary total knee replacement surgery
- No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
- BMI < 40
- Study patients should live within 100 km of our facility to ensure availability for follow-up
Key exclusion criteria (3 listed)
- Pregnancy or considering pregnancy
- BMI > 40
- Unable to undergo MRI screening
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 |
|---|---|---|
| Total Knee Arthroplasty with use of Visionaire Patient-Specific InstrumentationAlso: Visionaire Patient Specific InstrumentationThe manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery. | Device | Patient-Specific Instrumentation |
Primary outcome
Evaluating the Change in Implant Fixation assessed using RSA imaging
Time frame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.
1 secondary outcome
Patient Outcomes including Satisfaction
Time frame: Preoperatively, 1 year, 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- 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.
- Individual participant dataSharing planned: No
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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 Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation in people with Osteoarthritis, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating the Change in Implant Fixation assessed using RSA imaging (time frame: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years). 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 NCT02230215, 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 8 Nov 2018.