Osteoarthrosis, KneeAtt16SMNCT03077958
Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.
A study testing Total Knee Replacement (2 different design) in people with Osteoarthrosis, Knee, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthrosis, Knee
- What is being tested?
- Total Knee Replacement (2 different design)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 18 Feb 2017to 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
- Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees
- BMI <35
- ASA 1-3.
- Coming from independent living in own home
- Written informed consent
Who cannot join
- Cortisone treatment during the last 6 months before operation
- Neurological diseases with symptoms, stroke with sequel
- Endocrine diseases with symptoms
- OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
- BMI >=35
- OA of the hip with symptoms. (Patients operated with total hip arthroplasty are accepted)
- Ongoing infection
- Unable or unwilling to participate in the follow-up.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Orthopaedics
Mölndal, Västra Götaland County, S-43180
Johan N Kärrholm, MD, +46313422847, nils.karrholm@vgregion.se
Thom Magnusson, MD, +46313430861, thom.magnusson@vgregion.se
About this study
Official title: Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. Randomised Study of 50 Attune and 50 PFC Sigma Total Knee Replacements (TKRs)
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.
Read the detailed description
The Attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. One of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients are expected to experience improved function, better stability and less pain during activity. So far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as control.
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes. Patients can only participate with one knee.
Surgical procedure: The operations will be done according to our routines without use of bloodless field. Local analgesia will be infiltrated periarticulary during the operation. Cemented fixation will be used in all cases. So-called "fast-track"principles will be applied in both Groups.
Patients will be followed for five years.
- Conditions
- Osteoarthrosis, Knee
- Being tested
- Total Knee Replacement (2 different design)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Replacement (2 different design)Procedure or surgery
Also called Attune or PFC Sigma TKR
Patients will randomely receive either Attune or PFC Sigma TKR
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.
Measured: Preoperatively to 2 years
Secondary outcomes (3)
Patient satisfaction is reported on a visual analogue scale (VAS) 1-10
Patient satisfaction is reported on a visual analogue scale (VAS) 1-10
Measured: Preoperatively to 2 years
Knee Kinematics, (anterior-posterior translations and axial rotations)
Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up
Measured: 2 years
Pain (VAS)
Patient pain reported on Visual Analogue Scales(VAS) 1-10
Measured: Preoperatively to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start18 Feb 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthrosis, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with degenerative knee disease randomely receive one of two types of total knee prostheses
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Karrholm, Sahlgrenska University Hospital
- Investigators
- Johan Kärrholm, MD PhD Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077958
- Sponsor's protocol ID
- Attune2016SM
- Acronym
- Att16SM
- Status last verified
- Mar 2017
- First submitted
- 28 Apr 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared with the sponsor (DePuy).
Publications
Fandriks A, Zugner R, Shareghi B, Karrholm J, Tranberg R. Skin and cluster markers underestimate knee flexion during controlled motions. Evaluation of 12 patients with knee arthroplasty using radiosterometric analysis as reference. J Biomech. 2025 Mar;182:112591. doi: 10.1016/j.jbiomech.2025.112591. Epub 2025 Feb 17.
PubMed 39986061
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. Randomised Study of 50 Attune and 50 PFC Sigma Total Knee Replacements (TKRs)
- ClinicalTrials.gov ID
- NCT03077958
- Acronym / sponsor ID
- Att16SM / Attune2016SM
- Conditions
- Osteoarthrosis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Mar 2017 (actual)
- 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.
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.
Detailed description
The Attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. One of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients are expected to experience improved function, better stability and less pain during activity. So far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as control.
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes. Patients can only participate with one knee.
Surgical procedure: The operations will be done according to our routines without use of bloodless field. Local analgesia will be infiltrated periarticulary during the operation. Cemented fixation will be used in all cases. So-called "fast-track"principles will be applied in both Groups.
Patients will be followed for five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Model description
- Patients with degenerative knee disease randomely receive one of two types of total knee prostheses
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
- Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees
- BMI <35
- ASA 1-3.
- Coming from independent living in own home
Key exclusion criteria (8 listed)
- Cortisone treatment during the last 6 months before operation
- Neurological diseases with symptoms, stroke with sequel
- Endocrine diseases with symptoms
- OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
- BMI >=35
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 |
|---|---|---|
| Total Knee Replacement (2 different design)Also: Attune or PFC Sigma TKRPatients will randomely receive either Attune or PFC Sigma TKR | Procedure or surgery | – |
Primary outcome
Oxford Knee Score (OKS)
Time frame: Preoperatively to 2 years
The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.
3 secondary outcomes
Patient satisfaction is reported on a visual analogue scale (VAS) 1-10
Time frame: Preoperatively to 2 years
Knee Kinematics, (anterior-posterior translations and axial rotations)
Time frame: 2 years
Pain (VAS)
Time frame: Preoperatively to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 39986061Fandriks A, Zugner R, Shareghi B, Karrholm J, Tranberg R. Skin and cluster markers underestimate knee flexion during controlled motions. Evaluation of 12 patients with knee arthroplasty using radiosterometric analysis as reference. J Biomech. 2025 Mar;182:112591. doi: 10.1016/j.jbiomech.2025.112591. Epub 2025 Feb 17.
- Individual participant dataSharing planned: Undecided. Data will be shared with the sponsor (DePuy).
Related trials for Osteoarthrosis, Knee
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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.
Johan Kärrholm, MD PhD Professor principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Replacement (2 different design) in people with Osteoarthrosis, Knee, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 6 inclusion and 8 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 13 Mar 2017. 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 Sweden. 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?
Contact Johan N Kärrholm, MD, PhD (+46313428247, nils.karrholm@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score (OKS) (time frame: Preoperatively to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077958, which also lists 1 linked publication.
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 13 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.