Knee Osteoarthritis
Conditions
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.
Interventions
DEVICECruciate Retaining
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
DEVICEMedial Congruent
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.
Sponsors
Regional Hospital Holstebro
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinematics - knee joint movement | 1 year follow-up | Relative movement (position in millimetres and orientation in degrees) of the knee joint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Articular joint contact | 1 year follow-up | Contact between femur and tibia |
| Kinetic - knee joint contact force | 1 year follow-up | Internal knee forces (normal and share) of the femur and tibia |
| Implant inducible micromotion | 1 year follow-up | Quantifying dynamic inducible micromotion during daily activities. |
| Static implant migration | 3, 12 and 24 month post operation using first operative day as baseline. | baseline, three month after surgery and one year after surgery. |
| Patient Reported Output Measure | 1 year follow-up | Measured pre- and post operation |
Countries
Denmark
Outcome results
None listed