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

Not Applicable

Withdrawn

• Conditions: Rheumatoid Arthritis; Osteoarthritis, Knee; Valgus Deformity, Not Elsewhere Classified, Knee; Flexion Deformity, Knee; Post-Traumatic Osteoarthritis of Knee; Varus Deformity, Not Elsewhere Classified, Knee; Fracture of Upper End of Tibia; Fracture of Distal End of Femur
• Interventions: Device: Unity Knee™ TKR using measured resection; Device: Unity Knee™ TKR using ligament balancing

• Registration Number: NCT03511144
• Lead Sponsor: Corin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-27
• Study Start: 2018-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21
• Primary Completion: 2019-09
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Measured resection	Unity Knee™ TKR using measured resection	Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
Ligament balancing	Unity Knee™ TKR using ligament balancing	Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique

Primary Outcome Measures

Name	Time	Method
Posterior condylar offset (PCO)	6 weeks post-op	Any difference in PCO from preoperative to 6 weeks post-surgery

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	Up to 6 months post-op
Oxford Knee Score (OKS)	Up to 24 months post-op
Joint line in extension	6 weeks post-op	Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery
Joint line in flexion	6 weeks post-op	Any difference in medial joint line position measured using the PCO
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
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