Osteoarthritis ArthritisAPKnee2-S+NCT04037735
RSA-RCT: Attune S+ TKA Versus Sigma TKA
A study testing ATTUNE S+ Knee Prosthesis by DePuy and PFC Sigma Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Disease, run by Peter den Hollander at 1 site in Netherlands.
Trial summary
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Osteoarthritis Arthritis, Joint Disease, Musculoskeletal Disease
- What is being tested?
- ATTUNE S+ Knee Prosthesis by DePuy and PFC Sigma Knee Prosthesis by DePuy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2019to 1 Jun 2026
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with osteoarthritis and requires primary knee arthroplasty
- All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
Who cannot join
- The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
- Insufficiency of the posterior cruciate ligament (PCL)
- Status after patellectomy
- In case flexion is less than 90 degrees
- The patient is diagnosed with Rheumatoid Arthritis
- When it is expected that the tibia cut during surgery will compromise the attachment of the PCL (because of bony defects)
Show all 10Show fewer
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The patient does not understand the Dutch or English language good enough to participate
- Patients indicated for revision arthroplasty instruments because of bone defects or deformity of the bone
- When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Haaglanden Medical Center
The Hague, South Holland, 2501CK
Peter den Hollander, MD, +31 88 979 8087, p.den.hollander@haaglandenmc.nl
Peter den Hollander, MD
About this study
Official title: A Clinical Randomized Controlled RSA Trial Comparing the Cemented Attune (S+ Tibia Tray) Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up).
The Attune Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date, more than 470,000 patients have received an Attune Knee and positive feedback was received regarding patient recovery, stability and motion.
Read more
The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two knee prostheses: the Cemented Attune Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS.
This study is designed as a single-blind, randomized trial between the Attune Knee System and PFC Sigma Knee System. 32 patients with the Attune Knee System and 32 patients with PFC Sigma Knee System will be included in this study.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for knee replacement surgery at the Department of Orthopaedics, Haags Medisch Centrum The Hague (HMC), The Netherlands. Annually 350 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years.
Main study parameters/endpoints are:
- Migration, measured by means of RSA.
- Patient Reported Outcome Measures by means of questionnaires.
- Being tested
- ATTUNE S+ Knee Prosthesis by DePuy, PFC Sigma Knee Prosthesis by DePuy
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies
- Medical subject headings
- Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE S+ Knee Prosthesis by DePuyDevice
Total Knee Replacement (TKR) Surgery with ATTUNE S+ Knee Prosthesis by DePuy
PFC Sigma Knee Prosthesis by DePuyDevice
Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE | Experimental | Total Knee Replacement with the ATTUNE S+ Knee Prosthesis by DePuy Receives: Device: ATTUNE S+ Knee Prosthesis by DePuy |
| PFC Sigma | Active comparator | Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy Receives: Device: PFC Sigma Knee Prosthesis by DePuy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration, Maximum Total Point Motion (MTPM in mm) measured by means of Radiostereometry (RSA)
Compare the magnitude and pattern of migration of the prostheses (Tibial and Femoral component, smaller MTPM is better)
Migration is defined as the relative movement of the prosthesis with respect to the markers in the bone.
MTPM is defined as Maximum Total Point Motion, which means the amount of motion of the point that moves the most.
Measured: 2 Years
Secondary outcomes (3)
EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L)
General Health: EuroQol 3 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire; Index, 0 (worst possible) - 100 (best possible).
Measured: 2 Years
Knee injury and Osteoarthritis Outcome Score (KOOS-PS)
Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire; Index, 0 (worst possible) - 100 (best possible).
Measured: 2 Years
Visual Analogue Scale (VAS) pain
Pain score after activity and during rest; Likert scale 0 (no-pain) -10 (extreme pain).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Nov 2019
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ArthritisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter den Hollander
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor-investigator, Peter den Hollander, Medical Center Haaglanden
- Investigators
- Peter Hollander, MD, Principal investigator, Haaglanden Medical CenterRob G Nelissen, Prof., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037735
- Sponsor's protocol ID
- P18.131
- Other IDs
- NL66908.098.18
- Acronym
- APKnee2-S+
- Status last verified
- Oct 2023
- First submitted
- 26 Jul 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Randomized Controlled RSA Trial Comparing the Cemented Attune (S+ Tibia Tray) Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
- ClinicalTrials.gov ID
- NCT04037735
- Acronym / sponsor ID
- APKnee2-S+ / P18.131
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peter den HollanderUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jul 2019 (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 PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up).
The Attune Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date, more than 470,000 patients have received an Attune Knee and positive feedback was received regarding patient recovery, stability and motion.
The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two knee prostheses: the Cemented Attune Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS.
This study is designed as a single-blind, randomized trial between the Attune Knee System and PFC Sigma Knee System. 32 patients with the Attune Knee System and 32 patients with PFC Sigma Knee System will be included in this study.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for knee replacement surgery at the Department of Orthopaedics, Haags Medisch Centrum The Hague (HMC), The Netherlands. Annually 350 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years.
Main study parameters/endpoints are:
- Migration, measured by means of RSA.
- Patient Reported Outcome Measures by means of questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATTUNE | Experimental | Device: ATTUNE S+ Knee Prosthesis by DePuyTotal Knee Replacement with the ATTUNE S+ Knee Prosthesis by DePuy |
| PFC Sigma | Active comparator | Device: PFC Sigma Knee Prosthesis by DePuyTotal Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is diagnosed with osteoarthritis and requires primary knee arthroplasty
- All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
Key exclusion criteria (10 listed)
- The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The patient does not understand the Dutch or English language good enough to participate
- Patients indicated for revision arthroplasty instruments because of bone defects or deformity of the bone
- When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).
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 S+ Knee Prosthesis by DePuyTotal Knee Replacement (TKR) Surgery with ATTUNE S+ Knee Prosthesis by DePuy | Device | ATTUNE |
| PFC Sigma Knee Prosthesis by DePuyTotal Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy | Device | PFC Sigma |
Primary outcome
Migration, Maximum Total Point Motion (MTPM in mm) measured by means of Radiostereometry (RSA)
Time frame: 2 Years
Compare the magnitude and pattern of migration of the prostheses (Tibial and Femoral component, smaller MTPM is better) Migration is defined as the relative movement of the prosthesis with respect to the markers in the bone. MTPM is defined as Maximum Total Point Motion, which means the amount of motion of the point that moves the most.
3 secondary outcomes
EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L)
Time frame: 2 Years
Knee injury and Osteoarthritis Outcome Score (KOOS-PS)
Time frame: 2 Years
Visual Analogue Scale (VAS) pain
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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.
Peter Hollander, MD principal investigator
Haaglanden Medical Center
Rob G Nelissen, Prof. principal investigator
Leiden University Medical Center
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 S+ Knee Prosthesis by DePuy and PFC Sigma Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Disease, run by Peter den Hollander at 1 site in Netherlands.
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 3 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 30 Oct 2023. 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 Netherlands. 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 Peter Hollander, MD (+31 88 979 8087, P.den.Hollander@haaglandenmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration, Maximum Total Point Motion (MTPM in mm) measured by means of Radiostereometry (RSA) (time frame: 2 Years). 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 30 Oct 2023.