Osteoarthritis of KneeNCT02579174
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
A study testing Medacta GMK Sphere in people with Osteoarthritis of Knee, run by Northwestern University at 1 site in United States.
Trial summary
1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT) 2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants. 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Medacta GMK Sphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographically confirmed diagnosis of osteoarthritis (OA)
- Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
- Age greater than 18 years
- Desire to proceed with elective TKR
- Completion of informed consent and signature of written consent form
Who cannot join
- Ligamentous instability that may necessitate a constrained TKR implant
- Retained hardware in the distal femur or proximal tibia of the operative extremity
- Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Department of Orthopaedic Surgery
Chicago, Illinois, 60611
About this study
- To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)
- To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.
- To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT
Read the detailed description
Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.
Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.
The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Medacta GMK Sphere
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medacta GMK SphereDevice
| Study group | Role | What they receive |
|---|---|---|
| Manual (tibia) and manual (femur) | Other | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component Receives: Device: Medacta GMK Sphere |
| Manual (tibia) and custom (femur) | Other | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component Receives: Device: Medacta GMK Sphere |
| Custom (tibia) and custom (femur) | Other | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component Receives: Device: Medacta GMK Sphere |
| Custom (tibia) and manual (femur) | Other | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component Receives: Device: Medacta GMK Sphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Hip-Knee-Angle (HKA)
Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation
Measured: Pre-operative, 6 wks. post-op
Secondary outcomes (3)
Tibial Varus Deformity
Measured change between pre-operative planning report \& post-operative EOS longstanding radiograph in varus deformity of the operative joint
Measured: Pre-operative, 6 wks. post-op
Femoral Valgus Deformity
Measured change between pre-operative planning report \& post-operative EOS longstanding radiograph in varus deformity of the operative joint
Measured: Pre-operative, 6 wks. post-op
Tibial Posterior Slope (Mean Deviation)
Deviation from pre-operative planning template \& 6 wk. post-operative longstanding EOS radiograph
Measured: Pre-Operative - 6 wk. Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2015
- Primary completion8 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Manning, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579174
- Sponsor's protocol ID
- STU00200223
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2015
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
- ClinicalTrials.gov ID
- NCT02579174
- Acronym / sponsor ID
- STU00200223
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 15 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)
- To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.
- To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT
Detailed description
Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.
Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.
The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual (tibia) and manual (femur) | Other | Device: Medacta GMK SphereKnee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component |
| Manual (tibia) and custom (femur) | Other | Device: Medacta GMK SphereKnee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component |
| Custom (tibia) and custom (femur) | Other | Device: Medacta GMK SphereKnee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component |
| Custom (tibia) and manual (femur) | Other | Device: Medacta GMK SphereKnee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographically confirmed diagnosis of osteoarthritis (OA)
- Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
- Age greater than 18 years
- Desire to proceed with elective TKR
- Completion of informed consent and signature of written consent form
Key exclusion criteria (3 listed)
- Ligamentous instability that may necessitate a constrained TKR implant
- Retained hardware in the distal femur or proximal tibia of the operative extremity
- Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT
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 |
|---|---|---|
| Medacta GMK Sphere | Device | Custom (tibia) and custom (femur), Custom (tibia) and manual (femur), Manual (tibia) and custom (femur), Manual (tibia) and manual (femur) |
Primary outcome
Post-Operative Hip-Knee-Angle (HKA)
Time frame: Pre-operative, 6 wks. post-op
Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation
3 secondary outcomes
Tibial Varus Deformity
Time frame: Pre-operative, 6 wks. post-op
Femoral Valgus Deformity
Time frame: Pre-operative, 6 wks. post-op
Tibial Posterior Slope (Mean Deviation)
Time frame: Pre-Operative - 6 wk. Post-Operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medacta GMK Sphere in people with Osteoarthritis of Knee, run by Northwestern University at 1 site in United States.
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 5 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 15 Nov 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Operative Hip-Knee-Angle (HKA) (time frame: Pre-operative, 6 wks. post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2022.