Pre operatieve navigatie voor de plaatsing van een totale knie prothese. Wat doet de industrie?

Patient specific matched guides for total knee arthroplasty: A single surgeon experience with different systems

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29421

Enrollment

105

Registered

2014-08-13

Start date

2014-01-01

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

consecutive patients with debilitating osteoarthritis of the knee joint patient specific, TKA, industrie, alignment, cutting guide, pin guide,

Interventions

PSG from the following manufaturer TruMatch system Visionaire system Patient Specific Instrument system Signature system

Eligibility

Inclusion criteria

Inclusion criteria: - eligible for primary unilateral TKA - able and willing to participate - written consent

Exclusion criteria

Exclusion criteria: Patients who were not eligible to undergo MRI due to metal artefacts around the knee joint from previous surgery, claustrophobia, movement artefacts during MRI scanning time, pigmented villonodular synovitis (PVNS), implanted electronic devices (e.g. pacemaker, neurostimulator for bladder control or cochlear implants). Patients that refused to consent were excluded.

Design outcomes

Primary

Measure	Time frame
Pre operative approved planning for the femur and tibia component were compared with the post operative achieved alignment of each component on radiographs. Biomechanical limb alignment and implant position were measured with a calibrated protocol on digital images on a PACS system [Boonen et al 2012,Boonen et al 2013]. Biomechanical axis (HKA: Hip-Knee-Ankle angle) was evaluated on standardized 1-year postoperative coronal full leg standing radiographs. Varus/ valgus position of the femur (FFC) and tibia (FTC) components perpendicular to the HKA angle were measured on the same coronal radiographs.	—

Measure

Time frame

Pre operative approved planning for the femur and tibia component were compared with the post operative achieved alignment of each component on radiographs. Biomechanical limb alignment and implant position were measured with a calibrated protocol on digital images on a PACS system [Boonen et al 2012,Boonen et al 2013]. Biomechanical axis (HKA: Hip-Knee-Ankle angle) was evaluated on standardized 1-year postoperative coronal full leg standing radiographs. Varus/ valgus position of the femur (FFC) and tibia (FTC) components perpendicular to the HKA angle were measured on the same coronal radiographs.

—

Secondary

Measure	Time frame
Flexion/ extension of the femur component (LFC), measured from the anterior femoral cortex and posterior or anterior slope of the tibia component (LTC) measured from the posterior cortex of the tibia, were evaluated on 1-year postoperative lateral radiographs. Deviations >3 degrees between pre-operative planned HKA (sum of FFC and FTC) and individual components (FFC, FTC, LFC and LTC) compared to post operative achieved alignment on radiographs, were considered as outliers.	—

Measure

Time frame

Flexion/ extension of the femur component (LFC), measured from the anterior femoral cortex and posterior or anterior slope of the tibia component (LTC) measured from the posterior cortex of the tibia, were evaluated on 1-year postoperative lateral radiographs. Deviations >3 degrees between pre-operative planned HKA (sum of FFC and FTC) and individual components (FFC, FTC, LFC and LTC) compared to post operative achieved alignment on radiographs, were considered as outliers.

—

Contacts

Public ContactM.G.M. Schotanus

Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1

m.schotanus@orbisconcern.nl+31 (0)88 4597823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)