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NCT Number: NCT03633201

Anatomic Congruent Prosthetic Knee Design

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cruciate Retaining

Device

Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.

Other names: Persona Cruciate Retaining

Medial Congruent

Device

Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.

Other names: Persona Medial Congruent

Primary outcomes

  1. 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

  1. Articular joint contact

    Time frame: 1 year follow-up

    Contact between femur and tibia

  2. Kinetic - knee joint contact force

    Time frame: 1 year follow-up

    Internal knee forces (normal and share) of the femur and tibia

  3. Implant inducible micromotion

    Time frame: 1 year follow-up

    Quantifying dynamic inducible micromotion during daily activities.

  4. Static implant migration

    Time frame: 3, 12 and 24 month post operation using first operative day as baseline.

    baseline, three month after surgery and one year after surgery.

  5. Patient Reported Output Measure

    Time frame: 1 year follow-up

    Measured pre- and post operation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Regional Hospital Holstebro

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Aug 16, 2018
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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