Knee ArthroplastyNCT02791477
Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)
A study testing Attune FB PS knee arthroplasty in people with Knee Arthroplasty, run by Vestre Viken Hospital Trust at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Attune FB PS knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 50-80 years eligible for total knee arthroplasty at our hospital
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Vestre Viken HT, Baerum Hospital, Department of Medical Research
Sandvika, Akershus, 3004
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Arthroplasty
- Being tested
- Attune FB PS knee arthroplasty
- Keywords
- Attune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attune FB PS knee arthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Attune FB PS | Other | Attune FB PS knee arthroplasty Receives: Device: Attune FB PS knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score - (KOOS)
Knee injury and Osteoarthritis Outcome Score
Measured: 2 years postoperative
Secondary outcomes (8)
Forgotten Joint Score (FJS-12)
Forgotten Joint Score -12. Translated Norwegian version
Measured: 2 years postoperative
Quality of Life (EQ-5D)
Quality of life questionnaire
Measured: 2 years postoperative
University of California Los Angeles-Activity score
Record change in Activity level
Measured: 2 years postoperative
Range of Movement (ROM)
Range of movement pre- and postoperative
Measured: 2 years postoperative
Stair climbing test functional test
Time spend on walking up and down 9 stairs
Measured: 2 years postoperative
30 seconds stand up functional test
Number of stand ups from a chair in 30 seconds
Measured: 2 years postoperative
40 meters walking functional test
Time spend on walking 40 meters
Measured: 2 years postoperative
Visual Analogue Scale Satisfaction (VAS-satisfaction)
Scale for assesment of the satisfaction with the arthroplasty
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion1 Jul 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791477
- Sponsor's protocol ID
- Attune 2016
- Status last verified
- Apr 2021
- First submitted
- 11 May 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02791477
- Acronym / sponsor ID
- Attune 2016
- Conditions
- Knee Arthroplasty
- Keywords
- Attune
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attune FB PS | Other | Device: Attune FB PS knee arthroplastyAttune FB PS knee arthroplasty |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 50-80 years eligible for total knee arthroplasty at our hospital
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attune FB PS knee arthroplasty | Device | Attune FB PS |
Primary outcome
Knee injury and Osteoarthritis Outcome Score - (KOOS)
Time frame: 2 years postoperative
Knee injury and Osteoarthritis Outcome Score
8 secondary outcomes
Forgotten Joint Score (FJS-12)
Time frame: 2 years postoperative
Quality of Life (EQ-5D)
Time frame: 2 years postoperative
University of California Los Angeles-Activity score
Time frame: 2 years postoperative
Range of Movement (ROM)
Time frame: 2 years postoperative
Stair climbing test functional test
Time frame: 2 years postoperative
30 seconds stand up functional test
Time frame: 2 years postoperative
40 meters walking functional test
Time frame: 2 years postoperative
Visual Analogue Scale Satisfaction (VAS-satisfaction)
Time frame: 2 years postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attune FB PS knee arthroplasty in people with Knee Arthroplasty, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score - (KOOS) (time frame: 2 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.