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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis; Osteoarthritis, Knee; 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: Device: Unity Knee™ TKR using measured resection; Device: Unity Knee™ TKR using ligament balancing

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Corin

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Congenital Abnormalities; Fractures, Bone
• Other Study ID Numbers: CSP2015-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No