Anatomic Congruent Prosthetic Knee Design

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: Medial Congruent; Device: Cruciate Retaining

• Registration Number: NCT03633201
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Primary Completion: 2021-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medial Congruent	Medial Congruent	-
Cruciate Retaining	Cruciate Retaining	-

Primary Outcome Measures

Name	Time	Method
Kinematics - knee joint movement	1 year follow-up	Relative movement (position in millimetres and orientation in degrees) of the knee joint.

Secondary Outcome Measures

Name	Time	Method
Static implant migration	3, 12 and 24 month post operation using first operative day as baseline.	baseline, three month after surgery and one year after surgery.
Articular joint contact	1 year follow-up	Contact between femur and tibia
Implant inducible micromotion	1 year follow-up	Quantifying dynamic inducible micromotion during daily activities.
Kinetic - knee joint contact force	1 year follow-up	Internal knee forces (normal and share) of the femur and tibia
Patient Reported Output Measure	1 year follow-up	Measured pre- and post operation

Trial Locations

Locations (1)

University Clinic of Hand, Hip and Knee Surgery, Regional Hospital Holstebro; 🇩🇰 Holstebro, Denmark