OsteoarthritisPhase 4NCT01361152
Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old
A Phase 4 study testing anatomic modular fixed-bearing and low contact stress rotating platform mobile-bearing in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare 1. functional scores 2. Read more about this study
- Who is it for?
- Ages 29 to 50 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- anatomic modular fixed-bearing and low contact stress rotating platform mobile-bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 1993to Mar 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 29 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Who cannot join
- Inflammatory disease
- Patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age
The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare
- functional scores
- rates of radiographic failure
- revision rates
- survivorship
Read the detailed description
The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- anatomic modular fixed-bearing, low contact stress rotating platform mobile-bearing
- Keywords
- total knee arthroplasty, fixed-bearing, mobile-bearing, long-term
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anatomic modular fixed-bearingDevice
Also called AMK
anatomic modular (AMK; DePuy) fixed-bearing prosthesis
low contact stress rotating platform mobile-bearingDevice
Also called LCS RP
low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Fixed-bearing group | Experimental | Fixed-bearing group Receives: Device: anatomic modular fixed-bearing |
| Mobile-bearing group | Experimental | Mobile-bearing group Receives: Device: low contact stress rotating platform mobile-bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Knee Society Knee Score
change in knee score will be compared with initial score, until follow up of 18 years
Measured: 18 years
Secondary outcomes (1)
Improvement in the range of motion
change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startApr 1993
- Primary completionMar 1996
- Study completionMar 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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Young-Hoo Kim, MD, Study director, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361152
- Sponsor's protocol ID
- Fixed- and Mobile TKA
- Status last verified
- Oct 2011
- First submitted
- 17 May 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age
- ClinicalTrials.gov ID
- NCT01361152
- Acronym / sponsor ID
- Fixed- and Mobile TKA
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, fixed-bearing, mobile-bearing, long-term
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Apr 1993
- Primary completion
- Mar 1996 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 May 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.
The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare
- functional scores
- rates of radiographic failure
- revision rates
- survivorship
Detailed description
The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-bearing group | Experimental | Device: anatomic modular fixed-bearingFixed-bearing group |
| Mobile-bearing group | Experimental | Device: low contact stress rotating platform mobile-bearingMobile-bearing group |
Who may qualify
- Ages
- 29 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Key exclusion criteria (5 listed)
- Inflammatory disease
- Patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
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 |
|---|---|---|
| anatomic modular fixed-bearingAlso: AMKanatomic modular (AMK; DePuy) fixed-bearing prosthesis | Device | Fixed-bearing group |
| low contact stress rotating platform mobile-bearingAlso: LCS RPlow contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis | Device | Mobile-bearing group |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: 18 years
change in knee score will be compared with initial score, until follow up of 18 years
1 secondary outcome
Improvement in the range of motion
Time frame: 18 years
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 5 Oct 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.
Young-Hoo Kim, MD study director
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anatomic modular fixed-bearing and low contact stress rotating platform mobile-bearing in people with Osteoarthritis, run by Ewha Womans University 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 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: finished, as of the sponsor's last update on 5 Oct 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.
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?
Improvement in Knee Society Knee Score (time frame: 18 years). 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 5 Oct 2011.