Back to resultsAnatomic Congruent Prosthetic Knee Design
Primary Purpose
Knee Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cruciate Retaining
Medial Congruent
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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.
Sites / Locations
- University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Cruciate Retaining
Medial Congruent
Healthy Controls
Arm Description
Outcomes
Primary Outcome Measures
Kinematics - knee joint movement
Relative movement (position in millimetres and orientation in degrees) of the knee joint.
Secondary Outcome Measures
Articular joint contact
Contact between femur and tibia
Kinetic - knee joint contact force
Internal knee forces (normal and share) of the femur and tibia
Implant inducible micromotion
Quantifying dynamic inducible micromotion during daily activities.
Static implant migration
baseline, three month after surgery and one year after surgery.
Patient Reported Output Measure
Measured pre- and post operation
Full Information
NCT ID
NCT03633201
First Posted
January 18, 2018
Last Updated
August 11, 2023
Sponsor
University of Aarhus
Collaborators
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT03633201
Brief Title
Anatomic Congruent Prosthetic Knee Design
Official Title
Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Regional Hospital Holstebro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cruciate Retaining
Arm Type
Active Comparator
Arm Title
Medial Congruent
Arm Type
Active Comparator
Arm Title
Healthy Controls
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Cruciate Retaining
Other Intervention Name(s)
Persona Cruciate Retaining
Intervention Description
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
Intervention Type
Device
Intervention Name(s)
Medial Congruent
Other Intervention Name(s)
Persona Medial Congruent
Intervention Description
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.
Primary Outcome Measure Information:
Title
Kinematics - knee joint movement
Description
Relative movement (position in millimetres and orientation in degrees) of the knee joint.
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Articular joint contact
Description
Contact between femur and tibia
Time Frame
1 year follow-up
Title
Kinetic - knee joint contact force
Description
Internal knee forces (normal and share) of the femur and tibia
Time Frame
1 year follow-up
Title
Implant inducible micromotion
Description
Quantifying dynamic inducible micromotion during daily activities.
Time Frame
1 year follow-up
Title
Static implant migration
Description
baseline, three month after surgery and one year after surgery.
Time Frame
3, 12 and 24 month post operation using first operative day as baseline.
Title
Patient Reported Output Measure
Description
Measured pre- and post operation
Time Frame
1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maiken T Stilling, maiken.stilling@clin.au.dk
Organizational Affiliation
University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
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Anatomic Congruent Prosthetic Knee Design
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