Revision Total Knee Arthroplasty Because ofNavRevKnieNCT01601756
Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
A study testing navigated revision knee arthroplasty and conventional revision knee arthroplasty in people with Revision Total Knee Arthroplasty Because of and Loosening, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Revision Total Knee Arthroplasty Because of, Loosening, Instability
- What is being tested?
- navigated revision knee arthroplasty and conventional revision knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for revision knee arthroplasty
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Orthopaedic Department, Charité - University Medicine Berlin
Berlin, State of Berlin, 10117
Georg Matziolis, MD, +49 30 450 615093, georg.matziolis@charite.de
Georg Matziolis, MD
About this study
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).
- Conditions
- Revision Total Knee Arthroplasty Because of, Loosening, Instability, Impingement, or Other Reasons Accepted as Indications for TKA Exchange., The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty
- Being tested
- navigated revision knee arthroplasty, conventional revision knee arthroplasty
- Keywords
- revision knee arthroplasty, navigation, joint line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated revision knee arthroplastyDevice
revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).
conventional revision knee arthroplastyDevice
revision knee arthroplasty using conventional instruments
| Study group | Role | What they receive |
|---|---|---|
| navigated revision total knee arthroplasty | Experimental | revision total knee arthroplasty with the aid of a navigation system Receives: Device: navigated revision knee arthroplasty |
| conventional revision knee arthroplasty | Active comparator | revision knee arthroplasty using conventional instruments Receives: Device: conventional revision knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of Joint Line
Difference between preoperatively planned and postoperatively achieved joint line
Measured: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Knee Arthroplasty Because ofStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Responsible party
- Principal investigator, Georg Matziolis, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601756
- Sponsor's protocol ID
- AAG-I-H-0917
- Acronym
- NavRevKnie
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
- ClinicalTrials.gov ID
- NCT01601756
- Acronym / sponsor ID
- NavRevKnie / AAG-I-H-0917
- Conditions
- Revision Total Knee Arthroplasty Because of, Loosening, Instability, Impingement, or Other Reasons Accepted as Indications for TKA Exchange., The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty
- Keywords
- revision knee arthroplasty, navigation, joint line
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 18 May 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.
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigated revision total knee arthroplasty | Experimental | Device: navigated revision knee arthroplastyrevision total knee arthroplasty with the aid of a navigation system |
| conventional revision knee arthroplasty | Active comparator | Device: conventional revision knee arthroplastyrevision knee arthroplasty using conventional instruments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for revision knee arthroplasty
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| navigated revision knee arthroplastyrevision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen). | Device | navigated revision total knee arthroplasty |
| conventional revision knee arthroplastyrevision knee arthroplasty using conventional instruments | Device | conventional revision knee arthroplasty |
Primary outcome
Restoration of Joint Line
Time frame: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)
Difference between preoperatively planned and postoperatively achieved joint line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated revision knee arthroplasty and conventional revision knee arthroplasty in people with Revision Total Knee Arthroplasty Because of and Loosening, run by Charite University, Berlin, Germany at 1 site in Germany.
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 0 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 18 May 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Matziolis, MD (+49 30 450 615093, georg.matziolis@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of Joint Line (time frame: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)). 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 18 May 2012.