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

Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Device: Attune FB PS knee arthroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Sandvika, Akershus, Norway, 3004
      • Vestre Viken HT, Baerum Hospital, Department of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Attune FB PS; Attune FB PS knee arthroplasty	Device: Attune FB PS knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score - (KOOS)	Knee injury and Osteoarthritis Outcome Score	2 years postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Attune
• Other Study ID Numbers: Attune 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided