Prospective Randomized Trial of Navigated and Conventional TKA

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022099
• Other study ID #: KneeNavy
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: December 17, 2009
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Dresden, Orthopaedic Department	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lützner J, Krummenauer F, Wolf C, Günther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rotational component position		postoperatively	No
Secondary	leg axis		postoperatively	No
Secondary	kinematics		postoperatively	No
Secondary	clinical outcome		18 to 24 month postoperatively	No