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

Corin

Status: Withdrawn

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

Treatments: Device: Unity Knee™ TKR using measured resection; Device: Unity Knee™ TKR using ligament balancing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03511144

CSP2015-04

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Measured resection

Active Comparator group

Description:

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

Treatment:

Device: Unity Knee™ TKR using measured resection

Ligament balancing

Active Comparator group

Description:

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

Treatment:

Device: Unity Knee™ TKR using ligament balancing