Anatomic Congruent Prosthetic Knee Design

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Cruciate Retaining; Device: Medial Congruent

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy Controls
Active Comparator: Cruciate Retaining	Device: Cruciate Retaining; Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.; Other Names: Persona Cruciate Retaining
Active Comparator: Medial Congruent	Device: Medial Congruent; Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.; Other Names: Persona Medial Congruent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematics - knee joint movement	Relative movement (position in millimetres and orientation in degrees) of the knee joint.	1 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Articular joint contact	Contact between femur and tibia	1 year follow-up
Kinetic - knee joint contact force	Internal knee forces (normal and share) of the femur and tibia	1 year follow-up
Implant inducible micromotion	Quantifying dynamic inducible micromotion during daily activities.	1 year follow-up
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.
Patient Reported Output Measure	Measured pre- and post operation	1 year follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Regional Hospital Holstebro
• Investigators: Principal Investigator: Maiken T Stilling, maiken.stilling@clin.au.dk, University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): July 1, 2021
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: hev-knee-persona001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No