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

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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Withdrawn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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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