Prospective Randomized Trial of Navigated and Conventional TKA

Technische Universität Dresden

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Procedure: Implantation of a Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01022099

KneeNavy

Details and patient eligibility

About

Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.

Full description

1. 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.

2. 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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

navigated TKA

Active Comparator group

Treatment:

Procedure: Implantation of a Total Knee Arthroplasty

conventional TKA

Other group

Treatment:

Procedure: Implantation of a Total Knee Arthroplasty