Osteoarthritis of KneePhase 4NCT01027819

Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

A Phase 4 study testing Mobile bearing and Fixed bearing in people with Osteoarthritis of Knee, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteoarthritis of Knee
What is being tested?: Mobile bearing and Fixed bearing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteSouth Korea
Study dates: Nov 2009to Dec 2013
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

primary total knee arthroplasty

Who cannot join

infection
severe deformity in knee
revision

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, Seoul

Other trials in South Korea

About this study

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Read the detailed description

Double blind, randomized prospective study Mobile or fixed bearing of the same company

Mobile bearing group : group M
Fixed bearing group : group F

Inclusion criteria

patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

Range of motion
Complication
Scorings
KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

Alignment angles in knee
Positions of femoral and tibial components
Position of patella
Radiolucency

Conditions: Osteoarthritis of Knee
Being tested: Mobile bearing, Fixed bearing
Keywords: Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile bearingDevice
Also called Zimmer LPS-flex mobile bearing type polyethylene insert
Mobile bearing in total knee arthroplasty
Fixed bearingDevice
Also called Zimmer LPS-flex fixed bearing in polyethylene insert
Fixed bearing in total knee arthroplasty

Study groups in NCT01027819
Study group	Role	What they receive
Mobile bearing	Active comparator	Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty Receives: Device: Mobile bearing
Fixed bearing	Active comparator	Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty Receives: Device: Fixed bearing

What is being measured

The primary outcome is the main question the study is designed to answer.

Rotational Angle Between Femur and Tibia
Measured: 2 weeks

Secondary outcomes (1)

Knee Society Score
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Dec 2013

First posted9 Dec 2009 (estimated)
Study startNov 2009
Primary completionDec 2013 (estimated)

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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01027819
Sponsor's protocol ID: SNUHOSK09MBFB
Other IDs: SNUHOSK09MBFB
Status last verified: Dec 2012
First submitted: 7 Dec 2009
Last updated: 20 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis of Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT01027819
Acronym / sponsor ID: SNUHOSK09MBFB
Conditions: Osteoarthritis of Knee
Keywords: Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Nov 2009
Primary completion: Dec 2013 (estimated)
First posted: 9 Dec 2009 (estimated)
Results: Posted 5 Apr 2011

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 this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Detailed description

Double blind, randomized prospective study Mobile or fixed bearing of the same company

Mobile bearing group : group M
Fixed bearing group : group F

Inclusion criteria

patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

Range of motion
Complication
Scorings
KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

Alignment angles in knee
Positions of femoral and tibial components
Position of patella
Radiolucency

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mobile bearing	Active comparator	Device: Mobile bearingMobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
Fixed bearing	Active comparator	Device: Fixed bearingFixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

primary total knee arthroplasty

Key exclusion criteria (3 listed)

infection
severe deformity in knee
revision

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
Mobile bearingAlso: Zimmer LPS-flex mobile bearing type polyethylene insertMobile bearing in total knee arthroplasty	Device	Mobile bearing
Fixed bearingAlso: Zimmer LPS-flex fixed bearing in polyethylene insertFixed bearing in total knee arthroplasty	Device	Fixed bearing

Primary outcome

Rotational Angle Between Femur and Tibia
Time frame: 2 weeks

1 secondary outcome

Knee Society Score
Time frame: 6 months

Results and safety

Results posted to the registry on 5 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Bearing	40	40
Fixed Bearing	40	40

Primary outcome: Rotational Angle Between Femur and Tibia

Time frame: 2 weeks. Mean (Standard Deviation). Unit: degree

Measure	Mobile Bearing n = 40	Fixed Bearing n = 40
Value	-0.48 (2.18)	-0.66 (1.52)

Population analysed: The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Bearing	0 of 40 (0%)	0 of 40 (0%)	Not reported
Fixed Bearing	0 of 40 (0%)	0 of 40 (0%)	Not reported

Limitations and caveats (from the sponsor): First, our study population is composed of elderly patients with large female dominance Second concern was inherent errors in making the measurements in this kind of study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis of Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Myung Chul Lee, M.D., Ph. D. study director

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 Mobile bearing and Fixed bearing in people with Osteoarthritis of Knee, run by Seoul 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 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: status not confirmed, as of the sponsor's last update on 20 Dec 2012. 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?

Yes. Results are posted in the registry (first posted 5 Apr 2011). 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?

Rotational Angle Between Femur and Tibia (time frame: 2 weeks). 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 NCT01027819.

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 20 Dec 2012.