NCT01022099

Prospective Randomized Trial of Navigated and Conventional TKA

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
PROCEDURE	Implantation of a Total Knee Arthroplasty	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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-04-01
• Completion: 2008-12-01
• First posted: 2009-12-01
• Last updated: 2009-12-18

Locations

1 site across 1 country: Germany