A Comparison of Two Surgical Techniques Using the Unity Knee⢠Total Knee System (NCT03511144) | Clinical Trial Compass
WithdrawnNot Applicable
A Comparison of Two Surgical Techniques Using the Unity Knee⢠Total Knee System
Stopped: Study not initiated
0Started 2018-07
Plain-language summary
A comparison of two Unity Knee⢠tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
Who can participate
Age range18 Years
SexALL
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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 cā¦