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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02791477
Other study ID # Attune 2016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 31, 2022

Study information

Verified date April 2021
Source Vestre Viken Hospital Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 65
Est. completion date December 31, 2022
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Attune FB PS knee arthroplasty


Locations

Country Name City State
Norway Vestre Viken HT, Baerum Hospital, Department of Medical Research Sandvika Akershus

Sponsors (1)

Lead Sponsor Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee injury and Osteoarthritis Outcome Score - (KOOS) Knee injury and Osteoarthritis Outcome Score 2 years postoperative
Secondary Forgotten Joint Score (FJS-12) Forgotten Joint Score -12. Translated Norwegian version 2 years postoperative
Secondary Quality of Life (EQ-5D) Quality of life questionnaire 2 years postoperative
Secondary University of California Los Angeles-Activity score Record change in Activity level 2 years postoperative
Secondary Range of Movement (ROM) Range of movement pre- and postoperative 2 years postoperative
Secondary Stair climbing test functional test Time spend on walking up and down 9 stairs 2 years postoperative
Secondary 30 seconds stand up functional test Number of stand ups from a chair in 30 seconds 2 years postoperative
Secondary 40 meters walking functional test Time spend on walking 40 meters 2 years postoperative
Secondary Visual Analogue Scale Satisfaction (VAS-satisfaction) Scale for assesment of the satisfaction with the arthroplasty 2 years postoperative
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