Total Knee ReplacementNCT00512421
Navigated EM Total Knee Replacement: Accuracy Study
An observational study of Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- computer-assisted surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men and women that are candidates for total knee replacement.
Who may be able to join
- Signing informed consent
Who cannot join
- Pregnancy
- Soldiers in active military service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.
The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.
The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.
Read more
It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.
Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.
In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.
- Conditions
- Total Knee Replacement
- Being tested
- computer-assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A | navigation technique Receives: Procedure: computer-assisted surgery | |
| B | conservative surgery Receives: Procedure: computer-assisted surgery | |
| C | Historical control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Meir Libergall, Prof., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512421
- Sponsor's protocol ID
- LIB002-HMO-CTIL
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2007
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.
- ClinicalTrials.gov ID
- NCT00512421
- Acronym / sponsor ID
- LIB002-HMO-CTIL
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 7 Aug 2007 (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 use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.
The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.
It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.
Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.
In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: computer-assisted surgerynavigation technique |
| B | – | Procedure: computer-assisted surgeryconservative surgery |
| C | – | –Historical control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men and women that are candidates for total knee replacement.
Key inclusion criteria (1 listed)
- Signing informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Soldiers in active military service
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 |
|---|---|---|
| computer-assisted surgery | Procedure or surgery | A, B |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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.
Meir Libergall, Prof. principal investigator
Hadassah Medical Organization
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 Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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: stopped early, as of the sponsor's last update on 16 Sep 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 Israel. 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?
The study was stopped early. 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 16 Sep 2011; AzTrials last refreshed its copy on 28 Oct 2026.