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

Corin

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

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

Interventions

Unity Knee™ TKR using measured resectionDEVICE

Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique

Unity Knee™ TKR using ligament balancingDEVICE

Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Posterior condylar offset (PCO)

Any difference in PCO from preoperative to 6 weeks post-surgery

Time frame: 6 weeks post-op

Secondary Outcomes

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

Time frame: 6 weeks post-op

Joint line in flexion

Any difference in medial joint line position measured using the PCO

Time frame: 6 weeks post-op

Femoral flexion angle

Time frame: 6 weeks post-op

Distal femoral component angle

Time frame: 6 weeks post-op

Tibial component angle

Time frame: 6 weeks post-op

Tibial slope

Time frame: 6 weeks post-op

Hip-knee-ankle (HKA) angle

Time frame: 6 weeks post-op

Oxford Knee Score (OKS)

Time frame: Up to 24 months post-op

Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)

Time frame: Up to 24 months post-op

EuroQoL 5-dimension health state (EQ-5D 5-level)

Data from ClinicalTrials.gov

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