• 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…
ID
Bron
Verkorte titel
Aandoening
Patients who require TKA as a result of osteoarthritis of the knee and are candidates for the Vanguard TKA system.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• 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™
Achtergrond van het onderzoek
-
Doel van het onderzoek
• 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.
Onderzoeksopzet
Pre-, 6 weeks post and 1 year post operative
Onderzoeksproduct en/of interventie
TKA aligned either with the CT based Signature™ or the MRI based Signature™ alignment guide.
Publiek
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Wetenschappelijk
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4566 |
| NTR-old | NTR4734 |
| Ander register | - : 13T174 |