Clinical trial NCT02791477: Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)
Official title: Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Arthroplasty
Keywords: Attune
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score - (KOOS)
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Forgotten Joint Score (FJS-12)
timeFrame: 2 years postoperative
measure: Quality of Life (EQ-5D)
timeFrame: 2 years postoperative
measure: University of California Los Angeles-Activity score
timeFrame: 2 years postoperative
measure: Range of Movement (ROM)
timeFrame: 2 years postoperative
measure: Stair climbing test functional test
timeFrame: 2 years postoperative
measure: 30 seconds stand up functional test
timeFrame: 2 years postoperative
measure: 40 meters walking functional test
timeFrame: 2 years postoperative
measure: Visual Analogue Scale Satisfaction (VAS-satisfaction)
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Vestre Viken HT, Baerum Hospital, Department of Medical Research
state: Akershus
Study officials:
References: