Prospective Randomized Trial of Navigated and Conventional TKA

Study Overview
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Brief Summary
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Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.

Detailed Description
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Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA. A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge. clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.

Official Title
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Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Procedure: Implantation of a Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or secondary osteoarthritis of the knee indication to TKA a mechanical axis between 20° varus and 5° valgus signed informed consent Exclusion Criteria: previous hemi- or total arthroplasty severe instability that could not be treated with an unconstrained, cruciate-retaining TKA

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: navigated TKA<br> | Procedure: Implantation of a Total Knee Arthroplasty<br>* In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.<br>* Other names: Stryker Knee Navigation Software V3.1;|
| Other: conventional TKA<br> | Procedure: Implantation of a Total Knee Arthroplasty<br>* In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.<br>* Other names: Stryker Knee Navigation Software V3.1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rotational component position |  | postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leg axis |  | postoperatively | 
| kinematics |  | postoperatively | 
| clinical outcome |  | 18 to 24 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Navigation