Arthroplasty, Replacement, KneeNexGeNCT05464641
Randomised Total Knee Arthroplasty With Attune S+ or NexGen CR
A study testing Oxford knee score in people with Arthroplasty, Replacement, Knee, run by Göteborg University at 1 site in Sweden.
Trial summary
The primary purpose of this study is to evaluate the clinical performance of the Attune S+ knee primarily based on evaluation with use of Oxford Knee Score. The NexGen TKR will be used as reference standard. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Oxford knee score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 31 Jan 2024
- 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 OA Ahlbäck Grade 2-4
- Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
- Age 40-75 years
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Knee Arthroplasty With Attune S+ or NexGen CR Randomised Study of 150 TKR
The primary purpose of this study is to evaluate the clinical performance of the Attune S+ knee primarily based on evaluation with use of Oxford Knee Score. The NexGen TKR will be used as reference standard. The second aim is to study component migration with model-based RSA in a subgroup of patients with model-based RSA and to compare these measurements with migration measurements with use of CT-based migration measurements. The investigators hypothesis is that the results two years after insertion of these two TKR designs will be about equal.
Read the detailed description
The Attune knee was launched in 2012. From a clinical point of view some studies indicate superior clinical performance of the Attune when compared to the PFC. Carey and Harty operated 21 patients with both the Attune and the POFC Sigma knees. At six months' clinical scores were superior for the Attune side as was range of movement. Ranawat 2017, matched 100 Attune to 100 PFC Sigma knee operations based on age, gender, side and BMI but found no difference in clinical results after 2 years.
Bonutti reviewed three hospital databases and described 2 cases with loosening of the tibial component due to debonding between the cement and the implant, but the total material from which these cases were collected was not known or mentioned. Turgeon studied the fixation of 30 consecutive cases operated with the Attune knee and observed a mean maximum total point motion of 0.08 mm between 12 and 24 months, which suggests an acceptably low risk of medium to long-term failure due to aseptic loosening. Staats evaluated incidence of radiolucent lines in 276 Attune and 253 PFC Sigma TKRs up to one year after operation and observed a higher incidence in the former group.
In the last report from NJR from 2020, the 5-year revision rate of the Attune FB knee is 2.71 (2.32-3.17), which is slightly above average (2.23, 2.20-2.26). In the Australian registry from 2020 the corresponding cumulative percent revision rate of cemented Attune CR is 3.0 % (2.7 - 3.5) at 5 years.
In an ongoing study the investigators have randomized 95 knees with knee osteoarthritis to either become operated with an Attune knee (n=49) or a PFC knee (n=46). Preliminary results at one year show almost equal results when evaluated in terms of Oxford Knee or Forgotten Joint Scores.
NexGen metal-backed tibia is the most commonly used total knee prosthesis in Sweden. Its revision rate is one of the lowest observed in the Swedish Register. The 5 years survival in the report from NJR from 2020 is 2.1% (2.05 - 2.21) and in the report from the Australian register it is about equal (2.0; 1.9 - 2.2). The Australian Register also present survival at 19 years amounting to 5.7% (4.7 - 6.9) being the lowest cumulative revision of those specific cemented TKRs accounted for with that long follow up.
In 2017 DePuy launched the Attune S+ tibial components in order to address the potential problem of loosening between the cement and the tibial tray. If and if so, to what extent this modification will change the clinical outcome of TKRs operated with this implant is not known. Based on the high survival rate of the in Sweden frequently used NexGen TKR a comparative study between the Attune S+ and the NexGen TKRs would provide an important benchmark for the performance of the Attune S+ knee.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Oxford knee score
- Keywords
- Knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford knee scoreOther
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse
| Study group | Role | What they receive |
|---|---|---|
| preoperative | Active comparator | preoperative The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse. Receives: Other: Oxford knee score |
| postoperative | Active comparator | postoperative The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse. Receives: Other: Oxford knee score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford knee score
Oxford knee score, a 12-item patient-reported PRO
Measured: preoperative
Oxford knee score
Oxford knee score, a 12-item patient-reported PRO
Measured: 2 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- preoperative and 2 year postoperative
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Zügner, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464641
- Sponsor's protocol ID
- Attune S+ or NexGen CR
- Acronym
- NexGe
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty With Attune S+ or NexGen CR Randomised Study of 150 TKR
- ClinicalTrials.gov ID
- NCT05464641
- Acronym / sponsor ID
- NexGe / Attune S+ or NexGen CR
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Jul 2022 (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.
The primary purpose of this study is to evaluate the clinical performance of the Attune S+ knee primarily based on evaluation with use of Oxford Knee Score. The NexGen TKR will be used as reference standard. The second aim is to study component migration with model-based RSA in a subgroup of patients with model-based RSA and to compare these measurements with migration measurements with use of CT-based migration measurements. The investigators hypothesis is that the results two years after insertion of these two TKR designs will be about equal.
Detailed description
The Attune knee was launched in 2012. From a clinical point of view some studies indicate superior clinical performance of the Attune when compared to the PFC. Carey and Harty operated 21 patients with both the Attune and the POFC Sigma knees. At six months' clinical scores were superior for the Attune side as was range of movement. Ranawat 2017, matched 100 Attune to 100 PFC Sigma knee operations based on age, gender, side and BMI but found no difference in clinical results after 2 years.
Bonutti reviewed three hospital databases and described 2 cases with loosening of the tibial component due to debonding between the cement and the implant, but the total material from which these cases were collected was not known or mentioned. Turgeon studied the fixation of 30 consecutive cases operated with the Attune knee and observed a mean maximum total point motion of 0.08 mm between 12 and 24 months, which suggests an acceptably low risk of medium to long-term failure due to aseptic loosening. Staats evaluated incidence of radiolucent lines in 276 Attune and 253 PFC Sigma TKRs up to one year after operation and observed a higher incidence in the former group.
In the last report from NJR from 2020, the 5-year revision rate of the Attune FB knee is 2.71 (2.32-3.17), which is slightly above average (2.23, 2.20-2.26). In the Australian registry from 2020 the corresponding cumulative percent revision rate of cemented Attune CR is 3.0 % (2.7 - 3.5) at 5 years.
In an ongoing study the investigators have randomized 95 knees with knee osteoarthritis to either become operated with an Attune knee (n=49) or a PFC knee (n=46). Preliminary results at one year show almost equal results when evaluated in terms of Oxford Knee or Forgotten Joint Scores.
NexGen metal-backed tibia is the most commonly used total knee prosthesis in Sweden. Its revision rate is one of the lowest observed in the Swedish Register. The 5 years survival in the report from NJR from 2020 is 2.1% (2.05 - 2.21) and in the report from the Australian register it is about equal (2.0; 1.9 - 2.2). The Australian Register also present survival at 19 years amounting to 5.7% (4.7 - 6.9) being the lowest cumulative revision of those specific cemented TKRs accounted for with that long follow up.
In 2017 DePuy launched the Attune S+ tibial components in order to address the potential problem of loosening between the cement and the tibial tray. If and if so, to what extent this modification will change the clinical outcome of TKRs operated with this implant is not known. Based on the high survival rate of the in Sweden frequently used NexGen TKR a comparative study between the Attune S+ and the NexGen TKRs would provide an important benchmark for the performance of the Attune S+ knee.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- preoperative and 2 year postoperative
| Arm | Type | Receives |
|---|---|---|
| preoperative | Active comparator | Other: Oxford knee scorepreoperative The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse. |
| postoperative | Active comparator | Other: Oxford knee scorepostoperative The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medial or lateral primary OA Ahlbäck Grade 2-4
- Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
- Age 40-75 years
- BMI <35
- ASA 1-3.
Key exclusion criteria (5 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 |
|---|---|---|
| Oxford knee scoreThe Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse | Other | postoperative, preoperative |
Primary outcome
Oxford knee score
Time frame: preoperative
Oxford knee score, a 12-item patient-reported PRO
Oxford knee score
Time frame: 2 year postoperative
Oxford knee score, a 12-item patient-reported PRO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No. upon request
Related trials for Arthroplasty, Replacement, Knee
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Roland Zügner, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford knee score in people with Arthroplasty, Replacement, Knee, run by Göteborg University 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 25 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxford knee score (time frame: preoperative). The study lists 2 primary outcomes in all. 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 25 Apr 2025.