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

Primary Purpose

Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unity Knee™ TKR using measured resection
Unity Knee™ TKR using ligament balancing
Sponsored by
Corin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Measured resection

    Ligament balancing

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    Joint line in flexion
    Any difference in medial joint line position measured using the PCO
    Femoral flexion angle
    Distal femoral component angle
    Tibial component angle
    Tibial slope
    Hip-knee-ankle (HKA) angle
    Oxford Knee Score (OKS)
    Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)
    EuroQoL 5-dimension health state (EQ-5D 5-level)
    Hospital Anxiety and Depression Scale (HADS)

    Full Information

    First Posted
    April 11, 2018
    Last Updated
    November 20, 2018
    Sponsor
    Corin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03511144
    Brief Title
    A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
    Official Title
    A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study not initiated
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Corin

    4. Oversight

    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

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Measured resection
    Arm Type
    Active Comparator
    Arm Description
    Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
    Arm Title
    Ligament balancing
    Arm Type
    Active Comparator
    Arm Description
    Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
    Intervention Type
    Device
    Intervention Name(s)
    Unity Knee™ TKR using measured resection
    Intervention Description
    Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
    Intervention Type
    Device
    Intervention Name(s)
    Unity Knee™ TKR using ligament balancing
    Intervention Description
    Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
    Primary Outcome Measure Information:
    Title
    Posterior condylar offset (PCO)
    Description
    Any difference in PCO from preoperative to 6 weeks post-surgery
    Time Frame
    6 weeks post-op
    Secondary Outcome Measure Information:
    Title
    Joint line in extension
    Description
    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
    Title
    Joint line in flexion
    Description
    Any difference in medial joint line position measured using the PCO
    Time Frame
    6 weeks post-op
    Title
    Femoral flexion angle
    Time Frame
    6 weeks post-op
    Title
    Distal femoral component angle
    Time Frame
    6 weeks post-op
    Title
    Tibial component angle
    Time Frame
    6 weeks post-op
    Title
    Tibial slope
    Time Frame
    6 weeks post-op
    Title
    Hip-knee-ankle (HKA) angle
    Time Frame
    6 weeks post-op
    Title
    Oxford Knee Score (OKS)
    Time Frame
    Up to 24 months post-op
    Title
    Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)
    Time Frame
    Up to 24 months post-op
    Title
    EuroQoL 5-dimension health state (EQ-5D 5-level)
    Time Frame
    Up to 6 months post-op
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    Up to 6 months post-op

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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