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Clinical Trials/ACTRN12618001376235
ACTRN12618001376235
Recruiting
未知

A multi-centre, prospective randomised controlled trial to compare outcomes following modified kinematically aligned total knee arthroplasty using iTKR™ Software with those following mechanically aligned total knee arthroplasty.

Global Orthopaedic Technology0 sites102 target enrollmentAugust 16, 2018
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Global Orthopaedic Technology
Enrollment
102
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 16, 2018
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Global Orthopaedic Technology

Eligibility Criteria

Inclusion Criteria

  • •Participants must meet the following criteria to be considered eligible to enrol into the study:
  • •1\.Be over the age of 18 years;
  • •2\.Be capable of understanding the study requirements and of providing informed consent
  • •3\.Be eligible for a primary total knee replacement base on history, physical examination and radiological evaluation –
  • •4\.Have primary diagnosis of Osteoarthritis of the knee
  • •5\.Agree to attend the research centre for the required post\-operative assessments and radiological evaluation.
  • •6\.Pre\-operative varus/valgus angle 15 degrees or less

Exclusion Criteria

  • •Participants will be excluded from participating in the study if they meet any of the following exclusion criteria:
  • •1\.Not meeting the inclusion criteria.
  • •2\.BMI greater than 35
  • •3\.Haemoglobin A1c greater than 7
  • •4\.History of infection in the involved knee or current systemic infection
  • •5\.Previous fracture of the femur, tibia, patella or pelvis
  • •6\.Previous osteotomy of the affected knee
  • •7\.Previous ACL damage or repair
  • •8\.Not medically cleared to undergo a total knee replacement
  • •9\.American Society of Anaesthesiologists rating of 4 or greater

Outcomes

Primary Outcomes

Not specified

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