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

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ClinicalTrials.gov Identifier: NCT02791477
Recruitment Status : Active, not recruiting
First Posted : June 6, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

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.

Condition or disease Intervention/treatment Phase
Knee Arthroplasty Device: Attune FB PS knee arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty
Actual Study Start Date : May 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Attune FB PS
Attune FB PS knee arthroplasty
Device: Attune FB PS knee arthroplasty



Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score - (KOOS) [ Time Frame: 2 years postoperative ]
    Knee injury and Osteoarthritis Outcome Score


Secondary Outcome Measures :
  1. Forgotten Joint Score (FJS-12) [ Time Frame: 2 years postoperative ]
    Forgotten Joint Score -12. Translated Norwegian version

  2. Quality of Life (EQ-5D) [ Time Frame: 2 years postoperative ]
    Quality of life questionnaire

  3. University of California Los Angeles-Activity score [ Time Frame: 2 years postoperative ]
    Record change in Activity level

  4. Range of Movement (ROM) [ Time Frame: 2 years postoperative ]
    Range of movement pre- and postoperative

  5. Stair climbing test functional test [ Time Frame: 2 years postoperative ]
    Time spend on walking up and down 9 stairs

  6. 30 seconds stand up functional test [ Time Frame: 2 years postoperative ]
    Number of stand ups from a chair in 30 seconds

  7. 40 meters walking functional test [ Time Frame: 2 years postoperative ]
    Time spend on walking 40 meters

  8. Visual Analogue Scale Satisfaction (VAS-satisfaction) [ Time Frame: 2 years postoperative ]
    Scale for assesment of the satisfaction with the arthroplasty



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791477


Locations
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Norway
Vestre Viken HT, Baerum Hospital, Department of Medical Research
Sandvika, Akershus, Norway, 3004
Sponsors and Collaborators
Vestre Viken Hospital Trust

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Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT02791477     History of Changes
Other Study ID Numbers: Attune 2016
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vestre Viken Hospital Trust:
Attune