Total Knee ArthroplastyNCT00409266
CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty
A study testing Computer assisted navigation in people with Total Knee Arthroplasty, run by Stryker Instruments at 1 site in United States.
Trial summary
The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Computer assisted navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2007
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and Females over the age of 18 and equal to or less than the age of 60
- Patients scheduled for elective Total knee arthroplasty surgery
- Patients who have signed informed consent and HIPAA Authorization
- Able to speak and understand English
Who cannot join
- Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease
- Pregnant women
- Patients that will not sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthropla
The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Computer assisted navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer assisted navigationDevice
| Study group | Role | What they receive |
|---|---|---|
| Functional flexion axis of the knee | Other | The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles. Receives: Device: Computer assisted navigation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startJan 2007 (estimated)
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Investigator medical practice didn't allow to move forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Instruments
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R S Oliver, M.D., Principal investigator, Jordan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409266
- Sponsor's protocol ID
- NAV06-01US
- Status last verified
- Nov 2021
- First submitted
- 6 Dec 2006
- Last updated
- 10 Nov 2021
- Results posted
- No
Publications
Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82. doi: 10.1016/j.arth.2005.10.020.
PubMed 16950043
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthropla
- ClinicalTrials.gov ID
- NCT00409266
- Acronym / sponsor ID
- NAV06-01US
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator medical practice didn't allow to move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stryker InstrumentsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007 (estimated)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Dec 2006 (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 functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional flexion axis of the knee | Other | Device: Computer assisted navigationThe functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and Females over the age of 18 and equal to or less than the age of 60
- Patients scheduled for elective Total knee arthroplasty surgery
- Patients who have signed informed consent and HIPAA Authorization
- Able to speak and understand English
Key exclusion criteria (3 listed)
- Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease
- Pregnant women
- Patients that will not sign the informed consent
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 navigation | Device | Functional flexion axis of the knee |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 16950043Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82. doi: 10.1016/j.arth.2005.10.020.
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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.
R S Oliver, M.D. principal investigator
Jordan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer assisted navigation in people with Total Knee Arthroplasty, run by Stryker Instruments at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 10 Nov 2021. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
On the ClinicalTrials.gov record for NCT00409266, which also lists 1 linked publication.
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 10 Nov 2021.