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Anatomic Congruent Prosthetic Knee Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633201
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
Regional Hospital Holstebro
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Cruciate Retaining Device: Medial Congruent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cruciate Retaining Device: Cruciate Retaining
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
Other Name: Persona Cruciate Retaining
Active Comparator: Medial Congruent Device: Medial Congruent
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.
Other Name: Persona Medial Congruent
No Intervention: Healthy Controls


Outcome Measures
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Primary Outcome Measures :
  1. Kinematics - knee joint movement [ Time Frame: 1 year follow-up ]
    Relative movement (position in millimetres and orientation in degrees) of the knee joint.


Secondary Outcome Measures :
  1. Articular joint contact [ Time Frame: 1 year follow-up ]
    Contact between femur and tibia

  2. Kinetic - knee joint contact force [ Time Frame: 1 year follow-up ]
    Internal knee forces (normal and share) of the femur and tibia

  3. Implant inducible micromotion [ Time Frame: 1 year follow-up ]
    Quantifying dynamic inducible micromotion during daily activities.

  4. Static implant migration [ Time Frame: 3, 12 and 24 month post operation using first operative day as baseline. ]
    baseline, three month after surgery and one year after surgery.

  5. Patient Reported Output Measure [ Time Frame: 1 year follow-up ]
    Measured pre- and post operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed and written consent.
  • Primary knee osteoarthritis in capable men and women.
  • Indication for cruciate-retaining total knee arthroplasty.

Exclusion Criteria:

  • Patients who do not speak and read Danish.
  • Patients who are pregnant or at risk of becoming pregnant during the project.
  • Patients with active cancer and/or radiation or chemotherapy.
  • Patients who are alcoholics or have some form of abuse that impede information and follow-up.
  • Patients with severe psychiatric disease that might complicate compliance with follow-up.
  • Patients with surgically implants in the affected leg and/or pace maker.
  • Patients with greater thigh circumference then 60 cm.
  • Patients cannot perform the described exercises.
  • Patients with knee instability due to multiligament injury.
  • Patients with conditions that severely compromise their gait other than knee osteoarthritis in the affected knee.
  • Patients with severe fracture sequelae or severe malalignment at knee level.
  • Patients with osteosynthesised fractures using bone graft at knee level.
  • Patients with need of an augmentation and/or stem-elongation.
  • Patients with metabolic bone disease.
  • Patients with rheumatoid arthritis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633201


Locations
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Denmark
University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
University of Aarhus
Regional Hospital Holstebro
Investigators
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Principal Investigator: Maiken T Stilling, maiken.stilling@clin.au.dk University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03633201    
Other Study ID Numbers: hev-knee-persona001
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases