ACTRN12621000289819Recruiting未知
Multi-centre, observational study assessing clinical outcomes and patient satisfaction using kinematic alignment techniques for total knee replacement procedures.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Medacta Australia Pty Ltd
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
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
Investigators
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