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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03633201). StuddyBuddy aggregates publicly available trial information.