No registrations found.
ID
Source
Brief title
Health condition
Patients who require TKA as a result of osteoarthritis of the knee and are candidates for the Vanguard TKA system.
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Outliers in alignment of the femoral and tibial prosthesis in the frontal plane, measured on radiographs made 6 weeks after operation and compared between the CT-based Signature™ procedure and the standard MRI-based Signature™
Secondary outcome
• Fit and practical use of the guides
• Needed change of plans and reasons for changes
• Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components.
• Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg.
• Difference in thickness between the in vivo inserted polyethylene and the pre-operatively calculated thickness of this insert.
• Accurateness of guides: deviations from pre-operative digital plan.
Background summary
-
Study objective
• CT based Signature™ will result in a comparable percentage of prosthesis that is placed correctly (within guidelines of 3 degrees varus and 3 degrees valgus).
• CT-based Signature™ will result in a comparable alignment of the prosthesis as calculated by software and the actual alignment in vivo after knee surgery.
• CT-based Signature™ will result in comparable changes of plans.
• CT-based Signature™ will result in result in comparable percentages of outliers of the limb and of the individual prosthesis components.
Study design
Pre-, 6 weeks post and 1 year post operative
Intervention
TKA aligned either with the CT based Signature™ or the MRI based Signature™ alignment guide.
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Inclusion criteria
- Patients scheduled to undergo primary TKA replacement with any of the following indications
• Painful and disabled knee joint resulting from osteoarthritis.
• High need to obtain pain relief and improve function,
- Body-mass-index (BMI) <35
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- Consent form read, understood and signed by patient.
Exclusion criteria
- Active infection in knee
- General infection
- Distant foci of infections which may spread to the implant site
- Failure of previous joint replacement
- Pregnancy
- Previous major knee surgery, except for arthroscopic meniscectomy.
- Metal near knee joint (MRI-scan not possible)
- Not able or willing to undergo MRI-scan or CT-scan
- Rheumatoid arthritis
- Non-correctable varus axis
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4566 |
| NTR-old | NTR4734 |
| Other | - : 13T174 |