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

Knee Arthroplasty Clinical Trial

Official title:

Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02791477
• Other study ID #: Attune 2016
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Knee Arthroplasty

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