OsteoarthritisPhase 4NCT01422642
Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?
A Phase 4 study testing legacy posterior stabilized high-flexion (NexGen LPS-Flex) and legacy posterior stabilized standard (NexGen LPS) in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis. Read more about this study
- Who is it for?
- Ages 48 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- legacy posterior stabilized high-flexion (NexGen LPS-Flex) and legacy posterior stabilized standard (NexGen LPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2001to Jun 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 48 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older 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: Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up
The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.
Read the detailed description
We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.
- Conditions
- Osteoarthritis
- Being tested
- legacy posterior stabilized high-flexion (NexGen LPS-Flex), legacy posterior stabilized standard (NexGen LPS)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
legacy posterior stabilized high-flexion (NexGen LPS-Flex)Device
Also called NexGen LPS-Flex
NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
legacy posterior stabilized standard (NexGen LPS)Device
Also called NexGen LPS
NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
| Study group | Role | What they receive |
|---|---|---|
| legacy posterior stabilized high-flexion | Experimental | NexGen LPS-Flex total knee system Receives: Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex) |
| legacy posterior stabilized standard | Experimental | standard NexGen LPS prosthesis Receives: Device: legacy posterior stabilized standard (NexGen LPS) |
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 mean follow up of 10.3 year
Measured: 10 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 mean follow up of 10.3 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startJan 2001
- Primary completionApr 2001
- Study completionJun 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
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Investigators
- Young-Hoo Kim, MD, Study director, Ewha Womans University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422642
- Sponsor's protocol ID
- LPS-Flex vs LPS
- Status last verified
- Jun 2011
- First submitted
- 23 Aug 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up
- ClinicalTrials.gov ID
- NCT01422642
- Acronym / sponsor ID
- LPS-Flex vs LPS
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Apr 2001 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Aug 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 this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.
Detailed description
We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| legacy posterior stabilized high-flexion | Experimental | Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)NexGen LPS-Flex total knee system |
| legacy posterior stabilized standard | Experimental | Device: legacy posterior stabilized standard (NexGen LPS)standard NexGen LPS prosthesis |
Who may qualify
- Ages
- 48 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| legacy posterior stabilized high-flexion (NexGen LPS-Flex)Also: NexGen LPS-FlexNexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system | Device | legacy posterior stabilized high-flexion |
| legacy posterior stabilized standard (NexGen LPS)Also: NexGen LPSNexGen legacy posterior stabilized standard (NexGen LPS) total knee system | Device | legacy posterior stabilized standard |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: 10 years
change in knee score will be compared with initial score, until mean follow up of 10.3 year
1 secondary outcome
Improvement in the range of motion
Time frame: 10 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 30 Aug 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 School of Medicine
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 legacy posterior stabilized high-flexion (NexGen LPS-Flex) and legacy posterior stabilized standard (NexGen LPS) 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 30 Aug 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: 10 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 30 Aug 2011.