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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Posterior condylar offset (PCO)

Timeframe: 6 weeks post-op

Trial details

NCT IDNCT03511144

SponsorCorin

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.