NCT03633201

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
4mo left

Started Jul 2017

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2017Sep 2026

Study Start

First participant enrolled

July 11, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

January 18, 2018

Last Update Submit

August 20, 2025

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Kinematics - knee joint movement

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

    1 year follow-up

Secondary Outcomes (5)

  • Articular joint contact

    1 year follow-up

  • Kinetic - knee joint contact force

    1 year follow-up

  • Implant inducible micromotion

    1 year follow-up

  • Static implant migration

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

  • Patient Reported Output Measure

    1 year follow-up

Study Arms (3)

Cruciate Retaining

ACTIVE COMPARATOR
Device: Cruciate Retaining

Medial Congruent

ACTIVE COMPARATOR
Device: Medial Congruent

Healthy Controls

NO INTERVENTION

Interventions

Cruciate RetainingDEVICE

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

Also known as: Persona Cruciate Retaining
Cruciate Retaining
Medial CongruentDEVICE

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

Also known as: Persona Medial Congruent
Medial Congruent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed and written consent.
  • Primary knee osteoarthritis in capable men and women.
  • Indication for cruciate-retaining total knee arthroplasty.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maiken T Stilling, maiken.stilling@clin.au.dk

    University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

August 16, 2018

Study Start

July 11, 2017

Primary Completion

July 1, 2021

Study Completion (Estimated)

September 1, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)