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

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ClinicalTrials.gov Identifier: NCT03511144
Recruitment Status : Withdrawn (Study not initiated)
First Posted : April 27, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Corin

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

Condition or disease Intervention/treatment Phase
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 Device: Unity Knee™ TKR using measured resection Device: Unity Knee™ TKR using ligament balancing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Posterior condylar offset (PCO) [ Time Frame: 6 weeks post-op ]
    Any difference in PCO from preoperative to 6 weeks post-surgery


Secondary Outcome Measures :
  1. Joint line in extension [ Time Frame: 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

  2. Joint line in flexion [ Time Frame: 6 weeks post-op ]
    Any difference in medial joint line position measured using the PCO

  3. Femoral flexion angle [ Time Frame: 6 weeks post-op ]
  4. Distal femoral component angle [ Time Frame: 6 weeks post-op ]
  5. Tibial component angle [ Time Frame: 6 weeks post-op ]
  6. Tibial slope [ Time Frame: 6 weeks post-op ]
  7. Hip-knee-ankle (HKA) angle [ Time Frame: 6 weeks post-op ]
  8. Oxford Knee Score (OKS) [ Time Frame: Up to 24 months post-op ]
  9. Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS) [ Time Frame: Up to 24 months post-op ]
  10. EuroQoL 5-dimension health state (EQ-5D 5-level) [ Time Frame: Up to 6 months post-op ]
  11. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Up to 6 months post-op ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT03511144    
Other Study ID Numbers: CSP2015-04
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Congenital Abnormalities
Fractures, Bone
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries