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Clinical Trials/ACTRN12620000892910
ACTRN12620000892910
Not yet recruiting
未知

A randomised controlled trial comparing patient specific instrumentation (PSI)-kinematic alignment with PSI-mechanical alignment using a medial pivot design prosthesis to assess patient-reported functional outcomes

Whangarei Hospital0 sites138 target enrollmentSeptember 10, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Knee osteoarthritis
Sponsor
Whangarei Hospital
Enrollment
138
Status
Not yet recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 10, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Whangarei Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with end\-stage osteoarthritis (Kellgren\-Lawrence grade 3 or 4\) deemed suitable for total knee arthroplasty and have exhausted non operative management

Exclusion Criteria

  • Coronal \> 15 degrees and sagittal deformity of \>20 degrees
  • Mechanical lateral distal femur angle of 85\-95 degrees and mechanical medial proximal tibia angles of 85\-95 degrees
  • Patients who had previous open knee surgery that involved infection, osteotomy or fracture fixation
  • Patients with significant concomitant hip or spinal pathology making functional assessment of the knee replacement inaccurate
  • Contralateral knee pathology
  • Patients unable to complete or understand patient reported outcome assessment
  • BMI \> 40kg/m2
  • History of previous knee infection
  • Patients with neurological disease or neurosensory deficiency
  • inflammatory arthritis

Outcomes

Primary Outcomes

Not specified

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