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Prospective Randomized Trial of Navigated and Conventional TKA

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01022099
First received: November 30, 2009
Last updated: December 17, 2009
Last verified: December 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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

Locations
Germany
University Hospital Dresden, Orthopaedic Department
Dresden, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
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 Dresden University of Technology:
Total Knee Arthroplasty
Navigation

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

ClinicalTrials.gov processed this record on June 18, 2013