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Cost analysis of Pre operative navigation alignment in total knee arthroplasty compared to conventional instrumentation for total knee allignment.


- candidate number10754
- NTR NumberNTR3212
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2011
- Secondary IDs10T21 / 10.010 LAWO Orbis Medisch Centrum
- Public TitleCost analysis of Pre operative navigation alignment in total knee arthroplasty compared to conventional instrumentation for total knee allignment.
- Scientific TitleCost-benefit analyses of Patient Specific Instrumentation for Total Knee Arthroplasty compared to conventional instruments.
- ACRONYM
- hypothesisWe want to asses whether direct total hospital costs in terms of operation time, blood loss, drain use, hospitalization, sterilisation, are more progressive when using patient specific instruments for total knee arthroplasty compared to the conventional instruments for total knee alignment.
- Healt Condition(s) or Problem(s) studiedBlood loss, Hospitalization, Sterillisation
- Inclusion criteria1. Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
2. High need to obtain pain relief and improve function;
3. Above 18 years old;
4. Body-mass-index (BMI) <30;
5. Able and willing to follow instructions;
6. Written Informed consent.
- Exclusion criteria1. Active infection in knee;
2. General infection;
3. Distant foci of infections which may spread to the implant site;
4. Failure of previous joint replacement;
5. Pregnancy;
6. Previous osteotomy;
7. Prosthesis (hip, knee or ankle), intramedullary fixation or any kind of metal in the lower extremities or pelvis.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-sep-2011
- planned closingdate1-jun-2012
- Target number of participants90
- InterventionsThe Signature™ system addresses anatomic individuality with an image-based approach to interactive preoperative planning, visualization and creation of patient-specific surgical positioning guides:
1. The Signature™ system’s total knee application utilizes MRI or CT imaging, incorporating mechanical axis and traditional alignment philosophies;
2. The intuitive layout of the Signature™ Total Knee Planning Software provides a multitude of preoperative visualization options to fine-tune implant size and position and generate Signature™ positioning guides;
3. The Signature™ system, when used in conjunction with the Vanguard® Complete Knee System’s abundant femoral and tibial component size offerings, numerous tibial articulations and patellar sizes and thicknesses, optimizes clinical utility and addresses each patient’s soft-tissue requirements.

The control group will receive the standard treatment; the intramedullar allignment.
- Primary outcome1. Costs of operation time;
2. Blood loss;
3. Hospitalization;
4. Sterilisation;
5. Drain use;
6. Storage of prosthesis.
- Secondary outcomeQuallity of life (EQ5D).
- Timepoints1. Pre-operative;
2. 6 weeks;
3. 3 months;
4. One year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. B. Boonen
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum
- PublicationsN/A
- Brief summaryCost-effectiveness of treatment protocols is a hot topic when it comes to new surgical treatments and cost implications for the hospital. In practice total knee arthroplasty is an expensive procedure performed on an elective basis in hospital. Nowadays it is possible to replace a total knee due pre operative navigation, also known as patient specific instrumentation. Very little is known about the long term clinical outcome, the survival rate of implant and the financial consequence of this new innovative approach. The use of new surgical developments costs money, however, eventually provides a saving. We assessed whether direct total hospital costs in terms of operation time, blood loss, hospitalization, sterilization, are more progressive when using patient specific instruments for total knee arthroplasty compared to the conventional instruments for total knee alignment.

The purpose of this study was to evaluate short term savings for the hospital based on a patient matched cohort study, comparing Conventional Instruments (CI), the gold standard, with Patient Specific Instruments (PSI) for total knee arthroplasty.
- Main changes (audit trail)
- RECORD22-dec-2011 - 15-jan-2012


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