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

University of Aarhus1 site in 1 country75 target enrollmentJuly 11, 2017

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: University of Aarhus
Enrollment: 75
Locations: 1
Primary Endpoint: Kinematics - knee joint movement
Status: Active, Not Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 11, 2017

End Date

September 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Kinematics - knee joint movement

Time Frame: 1 year follow-up

Relative movement (position in millimetres and orientation in degrees) of the knee joint.

Secondary Outcomes

Static implant migration(3, 12 and 24 month post operation using first operative day as baseline.)
Articular joint contact(1 year follow-up)
Implant inducible micromotion(1 year follow-up)
Kinetic - knee joint contact force(1 year follow-up)
Patient Reported Output Measure(1 year follow-up)