Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)

NCT ID: NCT02791477

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2022-12-31

Brief Summary

Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6 weeks, 3, 6, 12 and 24 months postoperative.

Detailed Description

Total knee arthroplasty is a well documented and efficient treatment method for degenerative knee arthritis. Nevertheless it is reported that 15-20% of patients are not satisfied with the result. Some of the complaints are anterior knee pain, mid flexion instability and range of motion. Attune Fixed Bearing Posterior Stabilized knee have been developed to address the common complaints after knee arthroplasty surgery . The investigators like to use the Attune Fixed Bearing Posterior Stabilized knee with patella resurfacing on 65 of Our departments eligible patients to evaluate the functional results. Our primary outcome measure is change in Knee Osteoarthritis Outcome Score.

Conditions

Knee Arthroplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Attune FB PS

Attune FB PS knee arthroplasty

Group Type: OTHER

Attune FB PS knee arthroplasty

Intervention Type: DEVICE

Interventions

Attune FB PS knee arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients between 50-80 years eligible for total knee arthroplasty at our hospital

Exclusion Criteria

• Patients unable to cooperate
• Larger deformity that not suitable for a Posterior Stabilized total knee prostheses.
• Revision operation
• Diagnosed with inflammatory arthritis
• Previously septic arthritis in the current knee joint
• Local malignancy/general bone metastases
• Serious Medical conditions that inflict on the walking ability
• Active infections, latent infections og increased risk og infection
• Previously arthrodeses or not well functioned arthroplasties in hips, knees or ankles.
• Neurologic illness with symptoms from the current limb

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vestre Viken HT, Baerum Hospital, Department of Medical Research

Sandvika, Akershus, Norway

Countries

Norway

Other Identifiers

Attune 2016

Identifier Type: -

Identifier Source: org_study_id