Knee OsteoarthritisNCT03633201
Anatomic Congruent Prosthetic Knee Design
A study testing Cruciate Retaining and Medial Congruent in people with Knee Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cruciate Retaining and Medial Congruent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jul 2017to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed and written consent.
- Primary knee osteoarthritis in capable men and women.
- Indication for cruciate-retaining total knee arthroplasty.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro
Holstebro, 7500
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cruciate Retaining, Medial Congruent
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cruciate RetainingDevice
Also called Persona Cruciate Retaining
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
Medial CongruentDevice
Also called Persona Medial Congruent
Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.
| Study group | Role | What they receive |
|---|---|---|
| Cruciate Retaining | Active comparator | Not described Receives: Device: Cruciate Retaining |
| Medial Congruent | Active comparator | Not described Receives: Device: Medial Congruent |
| Healthy Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics - knee joint movement
Relative movement (position in millimetres and orientation in degrees) of the knee joint.
Measured: 1 year follow-up
Secondary outcomes (5)
Articular joint contact
Contact between femur and tibia
Measured: 1 year follow-up
Kinetic - knee joint contact force
Internal knee forces (normal and share) of the femur and tibia
Measured: 1 year follow-up
Implant inducible micromotion
Quantifying dynamic inducible micromotion during daily activities.
Measured: 1 year follow-up
Static implant migration
baseline, three month after surgery and one year after surgery.
Measured: 3, 12 and 24 month post operation using first operative day as baseline.
Patient Reported Output Measure
Measured pre- and post operation
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start11 Jul 2017
- Primary completion1 Jul 2021
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Hospital Holstebro
- Responsible party
- Sponsor
- Investigators
- Maiken T Stilling, maiken.stilling@clin.au.dk, Principal investigator, University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633201
- Sponsor's protocol ID
- hev-knee-persona001
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee
- ClinicalTrials.gov ID
- NCT03633201
- Acronym / sponsor ID
- hev-knee-persona001
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regional Hospital Holstebro
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cruciate Retaining | Active comparator | Device: Cruciate Retaining |
| Medial Congruent | Active comparator | Device: Medial Congruent |
| Healthy Controls | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed and written consent.
- Primary knee osteoarthritis in capable men and women.
- Indication for cruciate-retaining total knee arthroplasty.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cruciate RetainingAlso: Persona Cruciate RetainingZimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert. | Device | Cruciate Retaining |
| Medial CongruentAlso: Persona Medial CongruentZimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert. | Device | Medial Congruent |
Primary outcome
Kinematics - knee joint movement
Time frame: 1 year follow-up
Relative movement (position in millimetres and orientation in degrees) of the knee joint.
5 secondary outcomes
Articular joint contact
Time frame: 1 year follow-up
Kinetic - knee joint contact force
Time frame: 1 year follow-up
Implant inducible micromotion
Time frame: 1 year follow-up
Static implant migration
Time frame: 3, 12 and 24 month post operation using first operative day as baseline.
Patient Reported Output Measure
Time frame: 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiken T Stilling, maiken.stilling@clin.au.dk principal investigator
University clinic for hand, hip and knee surgery, Regional Hospital Holstebro, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cruciate Retaining and Medial Congruent in people with Knee Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics - knee joint movement (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.