A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System

A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System

A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.

Inclusion Criteria:

• Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
• Over 18 years old
• Male and female subjects who are skeletally mature
• Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
• Subjects able to understand what is expected of them and be able to comply with the study protocol requirements

Exclusion Criteria:

• Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
• Any subject with fixed flexion contracture greater than 20 degrees
• Any subject with varus/valgus deformity greater than 15 degrees
• Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
• Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
• Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
• Any subject with a known sensitivity to device material
• Any subject who is pregnant
• Any subject currently a prisoner
• Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
• Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
• Any subject unable to read and understand English