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

Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02791477
Enrollment
65
Registered
2016-06-06
Start date
2016-05-31
Completion date
2022-12-31
Last updated
2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

Attune

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.

Interventions

DEVICEAttune FB PS knee arthroplasty

Sponsors

Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Knee injury and Osteoarthritis Outcome Score - (KOOS)2 years postoperativeKnee injury and Osteoarthritis Outcome Score

Secondary

MeasureTime frameDescription
Quality of Life (EQ-5D)2 years postoperativeQuality of life questionnaire
University of California Los Angeles-Activity score2 years postoperativeRecord change in Activity level
Range of Movement (ROM)2 years postoperativeRange of movement pre- and postoperative
Forgotten Joint Score (FJS-12)2 years postoperativeForgotten Joint Score -12. Translated Norwegian version
30 seconds stand up functional test2 years postoperativeNumber of stand ups from a chair in 30 seconds
40 meters walking functional test2 years postoperativeTime spend on walking 40 meters
Visual Analogue Scale Satisfaction (VAS-satisfaction)2 years postoperativeScale for assesment of the satisfaction with the arthroplasty
Stair climbing test functional test2 years postoperativeTime spend on walking up and down 9 stairs

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026