Anatomic Congruent Prosthetic Knee Design

Study Overview
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Brief Summary
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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.

Official Title
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Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Cruciate Retaining
* Device: Medial Congruent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cruciate Retaining<br> | Device: Cruciate Retaining<br>* Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.<br>* Other names: Persona Cruciate Retaining;|
| Active Comparator: Medial Congruent<br> | Device: Medial Congruent<br>* Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.<br>* Other names: Persona Medial Congruent;|
| No Intervention: Healthy Controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics - knee joint movement | Relative movement (position in millimetres and orientation in degrees) of the knee joint. | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Articular joint contact | Contact between femur and tibia | 1 year follow-up | 
| Kinetic - knee joint contact force | Internal knee forces (normal and share) of the femur and tibia | 1 year follow-up | 
| Implant inducible micromotion | Quantifying dynamic inducible micromotion during daily activities. | 1 year follow-up | 
| Static implant migration | baseline, three month after surgery and one year after surgery. | 3, 12 and 24 month post operation using first operative day as baseline. | 
| Patient Reported Output Measure | Measured pre- and post operation | 1 year follow-up |