Anatomic Congruent Prosthetic Knee Design

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University of Aarhus

Status

Active, not recruiting

Conditions

Knee Osteoarthritis

Treatments

Device: Medial Congruent
Device: Cruciate Retaining

Study type

Interventional

Funder types

Other

Identifiers

NCT03633201
hev-knee-persona001

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups

Cruciate Retaining
Active Comparator group
Treatment:
Device: Cruciate Retaining
Medial Congruent
Active Comparator group
Treatment:
Device: Medial Congruent
Healthy Controls
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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