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Completed

NCT Number: NCT01022099

Prospective Randomized Trial of Navigated and Conventional TKA

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

About this study

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of a Total Knee Arthroplasty

Procedure

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

Primary outcomes

  1. rotational component position

    Time frame: postoperatively

Secondary outcomes

  1. leg axis

    Time frame: postoperatively

  2. kinematics

    Time frame: postoperatively

  3. clinical outcome

    Time frame: 18 to 24 month postoperatively

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 1, 2009
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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