Anatomic Congruent Prosthetic Knee Design

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cruciate Retaining

Group Type ACTIVE_COMPARATOR

Cruciate Retaining

Intervention Type DEVICE

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

Medial Congruent

Group Type ACTIVE_COMPARATOR

Medial Congruent

Intervention Type DEVICE

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

Healthy Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cruciate Retaining

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

Intervention Type DEVICE

Medial Congruent

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

Intervention Type DEVICE

Other Intervention Names

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Persona Cruciate Retaining Persona Medial Congruent

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes