Anatomic Congruent Prosthetic Knee Design

University of Aarhus

Status

Active, not recruiting

Conditions

Knee Osteoarthritis

Treatments

Device: Medial Congruent

Device: Cruciate Retaining

Study type

Interventional

Funder types

Other

Identifiers

NCT03633201

hev-knee-persona001

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.