Prospective Randomized Trial of Navigated and Conventional TKA
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Procedure: Implantation of a Total Knee Arthroplasty
- Registration Number
- NCT01022099
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- primary or secondary osteoarthritis of the knee
- indication to TKA
- a mechanical axis between 20° varus and 5° valgus
- signed informed consent
- previous hemi- or total arthroplasty
- severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description navigated TKA Implantation of a Total Knee Arthroplasty - conventional TKA Implantation of a Total Knee Arthroplasty -
- Primary Outcome Measures
Name Time Method rotational component position postoperatively
- Secondary Outcome Measures
Name Time Method leg axis postoperatively kinematics postoperatively clinical outcome 18 to 24 month postoperatively
Trial Locations
- Locations (1)
University Hospital Dresden, Orthopaedic Department
🇩🇪Dresden, Germany