A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
NCT ID: NCT03511144
Last Updated: 2018-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-07-31
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Measured resection
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
Unity Knee™ TKR using measured resection
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
Ligament balancing
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
Unity Knee™ TKR using ligament balancing
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
Interventions
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Unity Knee™ TKR using measured resection
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
Unity Knee™ TKR using ligament balancing
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Corin
INDUSTRY
Responsible Party
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Other Identifiers
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CSP2015-04
Identifier Type: -
Identifier Source: org_study_id
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