Anatomic Congruent Prosthetic Knee Design

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03633201
• Other study ID #: hev-knee-persona001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Cruciate Retaining
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
• Medial Congruent
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.

Locations

Country	Name	City	State
Denmark	University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro	Holstebro

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics - knee joint movement	Relative movement (position in millimetres and orientation in degrees) of the knee joint.	1 year follow-up
Secondary	Articular joint contact	Contact between femur and tibia	1 year follow-up
Secondary	Kinetic - knee joint contact force	Internal knee forces (normal and share) of the femur and tibia	1 year follow-up
Secondary	Implant inducible micromotion	Quantifying dynamic inducible micromotion during daily activities.	1 year follow-up
Secondary	Static implant migration	baseline, three month after surgery and one year after surgery.	3, 12 and 24 month post operation using first operative day as baseline.
Secondary	Patient Reported Output Measure	Measured pre- and post operation	1 year follow-up