OsteoarthritisNCT01379755
Comparison of Stability and Outcomes in Single-radius Femoral Component for Total Knee Arthroplasty
An observational study of Osteoarthritis, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
This is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 48 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 213 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jul 2011
- Phase
- Observational
- 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 48 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 56 total knee arthroplasties(TKAs) with a single-radius femoral design (Scorpio NRG) (single-radius(SR) group) and 59 total knee arthroplasties(TKAs) with multiradius femoral design (NexGen CR) (multi-radius(MR) group)
Who may be able to join
- followed for a minimum of two years.
Who cannot join
- Not followed for a minimum of two years.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Center for Joint Disease, Chonnam National University Hwasun Hospital
Hwasun-Gun, Jeollanam-do, 519-809
About this study
Official title: Study of Compare Mid-flexion Stability and Clinical Outcomes in Single-radius Femoral Design or Multi-radius Femoral Design.
This is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty.
Read the detailed description
Recently, femoral designs based on a sagittal single radius were designed to allow better mid-flexion stability and extensor function after total knee arthroplasty. The purpose of this study was to compare mid-flexion stability and clinical outcomes in patients that received TKA using either a single-radius femoral design or multi-radius femoral design.
- Conditions
- Osteoarthritis
- Keywords
- stability, single-radius, multi-radius, total knee arthroplasty
- Medical subject headings
- Osteoarthritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionJul 2011 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jong Keun Seon, Professor, Study director, Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379755
- Sponsor's protocol ID
- singleradius
- Other IDs
- singleradius2
- Status last verified
- Jun 2011
- First submitted
- 8 Jun 2011
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Compare Mid-flexion Stability and Clinical Outcomes in Single-radius Femoral Design or Multi-radius Femoral Design.
- ClinicalTrials.gov ID
- NCT01379755
- Acronym / sponsor ID
- singleradius
- Conditions
- Osteoarthritis
- Keywords
- stability, single-radius, multi-radius, total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 23 Jun 2011 (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 is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty.
Detailed description
Recently, femoral designs based on a sagittal single radius were designed to allow better mid-flexion stability and extensor function after total knee arthroplasty. The purpose of this study was to compare mid-flexion stability and clinical outcomes in patients that received TKA using either a single-radius femoral design or multi-radius femoral design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 48 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 56 total knee arthroplasties(TKAs) with a single-radius femoral design (Scorpio NRG) (single-radius(SR) group) and 59 total knee arthroplasties(TKAs) with multiradius femoral design (NexGen CR) (multi-radius(MR) group)
Key inclusion criteria (1 listed)
- followed for a minimum of two years.
Key exclusion criteria (1 listed)
- Not followed for a minimum of two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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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.
Jong Keun Seon, Professor study director
Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Chonnam National University Hospital at 1 site in South Korea.
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 1 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 14 Jul 2011. 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 South Korea. 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.
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 14 Jul 2011.