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Clinical Trials/NCT01022099
NCT01022099
Completed
Not Applicable

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

Technische Universität Dresden1 site in 1 country80 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis of the Knee
Sponsor
Technische Universität Dresden
Enrollment
80
Locations
1
Primary Endpoint
rotational component position
Status
Completed
Last Updated
16 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
December 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

rotational component position

Time Frame: postoperatively

Secondary Outcomes

  • leg axis(postoperatively)
  • kinematics(postoperatively)
  • clinical outcome(18 to 24 month postoperatively)

Study Sites (1)

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