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Active Not Recruiting
NCT03633201
Anatomic Congruent Prosthetic Knee Design
Conditions: Knee Osteoarthritis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 75
Sponsor: University of Aarhus
Location: University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro Holstebro
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.
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.
Source: ClinicalTrials.gov (NCT03633201). StuddyBuddy aggregates publicly available trial information.