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

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

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

Conditions
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Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee, Varus Deformity, Not Elsewhere Classified, Knee, Valgus Deformity, Not Elsewhere Classified, Knee, Flexion Deformity, Knee, Fracture of Distal End of Femur, Fracture of Upper End of Tibia

Intervention / Treatment
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* Device: Unity Knee™ TKR using measured resection
* Device: Unity Knee™ TKR using ligament balancing


Participation Criteria
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Eligibility Criteria
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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 compensations claims Any subject unable to read and understand English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Measured resection<br>Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique | Device: Unity Knee™ TKR using measured resection<br>* Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique<br>|
| Active Comparator: Ligament balancing<br>Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique | Device: Unity Knee™ TKR using ligament balancing<br>* Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior condylar offset (PCO) | Any difference in PCO from preoperative to 6 weeks post-surgery | 6 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint line in extension | Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery | 6 weeks post-op | 
| Joint line in flexion | Any difference in medial joint line position measured using the PCO | 6 weeks post-op | 
| Femoral flexion angle |  | 6 weeks post-op | 
| Distal femoral component angle |  | 6 weeks post-op | 
| Tibial component angle |  | 6 weeks post-op | 
| Tibial slope |  | 6 weeks post-op | 
| Hip-knee-ankle (HKA) angle |  | 6 weeks post-op | 
| Oxford Knee Score (OKS) |  | Up to 24 months post-op | 
| Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS) |  | Up to 24 months post-op | 
| EuroQoL 5-dimension health state (EQ-5D 5-level) |  | Up to 6 months post-op | 
| Hospital Anxiety and Depression Scale (HADS) |  | Up to 6 months post-op |