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Clinical Trials/ACTRN12621000289819
ACTRN12621000289819
Recruiting
未知

Multi-centre, observational study assessing clinical outcomes and patient satisfaction using kinematic alignment techniques for total knee replacement procedures.

Medacta Australia Pty Ltd0 sites150 target enrollmentMarch 16, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Medacta Australia Pty Ltd
Enrollment
150
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 16, 2021
End Date
TBD
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with a previous diagnosis of end\-stage osteoarthritis who have undergone primary total knee arthoplasty using kinematic alignment techniques.
  • \- Patients who understand the study conditions and are willing/able to provide written consent for participation in the study.
  • \- Patients who received a GMK Sphere Medacta Medially Stablised Knee Implant based on on\-label usage.
  • \- Aged over 18 years

Exclusion Criteria

  • \- Patients who experienced an adverse event post\-surgery unrelated to device implant
  • \- Patients with a history or are currently being treated for psychiatric illness/mental disorder
  • \- Evidence of either acute or chronic infection either pre or post\-surgery
  • \- Patients who have had significant prior surgery or trauma to the affected knee (e.g. prior High Tibial Osteotomy, periarticular fracture, recurrent patella dislocation)
  • \- Patients with a history or are currently being treated for alcohol or drug abuse

Outcomes

Primary Outcomes

Not specified

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