OsteoarthritisPhase 4NCT01520571
Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
A Phase 4 study testing Non-Computer Assistance TKA and Computer Assistance TKA in people with Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a… Read more about this study
- Who is it for?
- Ages 49 to 88 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Non-Computer Assistance TKA and Computer Assistance TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2000to Dec 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 49 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
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
The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?
Read the detailed description
Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.
- Conditions
- Osteoarthritis
- Being tested
- Non-Computer Assistance TKA, Computer Assistance TKA
- Keywords
- Computer Assistance, Total Knee Arthroplasty, conventional
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Computer Assistance TKAProcedure or surgery
Also called Non-Computer Assistance Total Knee Arthroplasty
Non-Computer Assistance Total Knee Arthroplasty
Computer Assistance TKAProcedure or surgery
Also called Computer Assistance Total Knee Arthroplasty
Computer Assistance Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Non-Computer Assistance TKA | Active comparator | Non-Computer Assistance TKA Receives: Procedure: Non-Computer Assistance TKA |
| Computer Assistance TKA | Experimental | Computer Assistance TKA Receives: Procedure: Computer Assistance TKA |
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 10.5 years
Measured: 10.5 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 10.5 years.
Measured: 10.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2000
- Primary completionDec 2001
- Study completionDec 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
- 520 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 School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520571
- Sponsor's protocol ID
- Computer Assistance TKA
- Status last verified
- Jan 2012
- First submitted
- 19 Jan 2012
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
- ClinicalTrials.gov ID
- NCT01520571
- Acronym / sponsor ID
- Computer Assistance TKA
- Conditions
- Osteoarthritis
- Keywords
- Computer Assistance, Total Knee Arthroplasty, conventional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jan 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 investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?
Detailed description
Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Computer Assistance TKA | Active comparator | Procedure: Non-Computer Assistance TKANon-Computer Assistance TKA |
| Computer Assistance TKA | Experimental | Procedure: Computer Assistance TKAComputer Assistance TKA |
Who may qualify
- Ages
- 49 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
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 |
|---|---|---|
| Non-Computer Assistance TKAAlso: Non-Computer Assistance Total Knee ArthroplastyNon-Computer Assistance Total Knee Arthroplasty | Procedure or surgery | Non-Computer Assistance TKA |
| Computer Assistance TKAAlso: Computer Assistance Total Knee ArthroplastyComputer Assistance Total Knee Arthroplasty | Procedure or surgery | Computer Assistance TKA |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: 10.5 years
change in knee score will be compared with initial score, until follow up of 10.5 years
1 secondary outcome
Improvement in the range of motion
Time frame: 10.5 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 Jan 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.
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 Non-Computer Assistance TKA and Computer Assistance TKA 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 Jan 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?
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: 10.5 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 Jan 2012.