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

Cost-benefit analyses of Patient Specific Instrumentation for Total Knee Arthroplasty compared to conventional instruments.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29430
Enrollment
90
Registered
2011-12-22
Start date
2011-09-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodloss, Hospitalization, Sterillisation, less instruments, storage, navigation, allignment, jigs

Interventions

The Signature™ system addresses anatomic individuality with an image-based approach to interactive preoperative planning, visualization and creation of patient-specific surgical positioning guides: 1
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™ positio
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
the intramedullar allignment.

Sponsors

NP Kort (MD, PhD), Orthopedic Surgeon Postaddress Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1 Address postalcode 6162 BG city Geleen country The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
1. Costs of operation time; 2. Blood loss; 3. Hospitalization; 4. Sterilisation; 5. Drain use; 6. Storage of prosthesis.

Secondary

MeasureTime frame
Quallity of life (EQ5D).

Contacts

Public ContactB. Boonen

Orthopedic Department, Orbis Medisch Centrum dr H van de Hoffplein 1

boonenbert@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)