OsteoarthritisPhase 4NCT01751334
Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
A Phase 4 study testing total knee arthroplasty in people with Osteoarthritis, run by Seoul National University Hospital.
Trial summary
The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Aug 2011
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary osteoarthritis
Who cannot join
- infection
- inflammatory arthritis
- reoperation
- severe deformity
About this study
The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).
Read the detailed description
Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.
- Conditions
- Osteoarthritis
- Being tested
- total knee arthroplasty
- Keywords
- Arthroplasty, Replacement, Knee, Rotational Alignment
- 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 arthroplastyDevice
Also called Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA
Mobile Bearing Total knee Arthroplasty
total knee arthroplastyDevice
Also called Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA
Fixed Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Mobile Bearing | Experimental | Mobile bearing total knee arthroplasty Receives: Device: total knee arthroplasty |
| Fixed Bearing | Active comparator | Fixed Bearing total knee arthroplasty Receives: Device: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial anteroposterior axis relative to femoral anteroposterior axis
Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images
Measured: postoperative 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startSep 2005
- Primary completionAug 2006
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahnghoon Lee, M.D., Ph.D., Principal investigatorMyung Chul Lee, M.D., Ph.D., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751334
- Sponsor's protocol ID
- SNUHOSKNEE01-RPFLPSF
- Status last verified
- Dec 2012
- First submitted
- 13 Dec 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01751334
- Acronym / sponsor ID
- SNUHOSKNEE01-RPFLPSF
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee, Rotational Alignment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Dec 2012 (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.
The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).
Detailed description
Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Bearing | Experimental | Device: total knee arthroplastyMobile bearing total knee arthroplasty |
| Fixed Bearing | Active comparator | Device: total knee arthroplastyFixed Bearing total knee arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary osteoarthritis
Key exclusion criteria (4 listed)
- infection
- inflammatory arthritis
- reoperation
- severe deformity
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 arthroplastyAlso: Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USAMobile Bearing Total knee Arthroplasty | Device | Mobile Bearing |
| total knee arthroplastyAlso: Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USAFixed Total Knee Arthroplasty | Device | Fixed Bearing |
Primary outcome
Tibial anteroposterior axis relative to femoral anteroposterior axis
Time frame: postoperative 2 weeks
Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images
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 18 Dec 2012.
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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.
Sahnghoon Lee, M.D., Ph.D. principal investigator
Myung Chul Lee, M.D., Ph.D. study chair
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing total knee arthroplasty in people with Osteoarthritis, run by Seoul National University Hospital.
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 1 inclusion and 4 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 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tibial anteroposterior axis relative to femoral anteroposterior axis (time frame: postoperative 2 weeks). 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 18 Dec 2012.