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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12621000289819
• Lead Sponsor: Medacta Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Oxford Knee Questionnaire Scores (OKS) to assess function and pain after total knee replacement.[2 years post-surgery]