Prospective Randomized Trial of Navigated and Conventional TKA

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01022099
First received: November 30, 2009
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention
Osteoarthritis of the Knee
Procedure: Implantation of a Total Knee Arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • rotational component position [ Time Frame: postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • leg axis [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
  • kinematics [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
  • clinical outcome [ Time Frame: 18 to 24 month postoperatively ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: navigated TKA 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.

Other Names:
  • ScorpioTM PCS
  • Stryker Navigation System
  • Stryker Knee Navigation Software V3.1
conventional TKA 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.

Other Names:
  • ScorpioTM PCS
  • Stryker Navigation System
  • Stryker Knee Navigation Software V3.1

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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022099

Locations
Germany
University Hospital Dresden, Orthopaedic Department
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Study Director: Klaus-Peter Günther, MD, PhD Orthopaedic Department, University Hospital Dresden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dresden University of Technology, Dr Joerg Luetzner, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01022099     History of Changes
Other Study ID Numbers: KneeNavy
Study First Received: November 30, 2009
Last Updated: December 17, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Total Knee Arthroplasty
Navigation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014