Osteoarthritis ArthritisAPKneeNCT02256098
RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA
A study testing ATTUNE™ Knee Prosthesis by DePuy and PFC Sigma Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Diseases, run by Leiden University Medical Center at 2 sites 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)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Osteoarthritis Arthritis, Joint Diseases, Musculoskeletal Diseases
- What is being tested?
- ATTUNE™ 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
- 74 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2014to 2 Nov 2017
- 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 or rheumatoid arthritis and requiring 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
- When it is expected that the tibia cut during surgery will compromise the attachment of the PCL (because of bony defects)
- The patient is unable or unwilling to sign the Informed Consent specific to this study
Show all 9Show fewer
- The patient does not understand the Dutch or English language good enough to participate
- Patients indicated for revision arthroplasty
- 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
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300RC
Medisch Centrum Haaglanden
The Hague, 2501CK
About this study
Official title: A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE™ 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)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009).
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 (March 2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch 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 TKR 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. The tertiary objective of this study is to compare clinical and radiological outcome and PROMS of the prostheses with migration data.
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 TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The Hague, The Netherlands. Annually 300 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 of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
- Patient Reported Outcome Measures by means of questionnaires.
- Being tested
- ATTUNE™ Knee Prosthesis by DePuy, PFC Sigma Knee Prosthesis by DePuy
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies, Arthroplasty, Replacement, Knee/methods
- 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™ Knee Prosthesis by DePuyDevice
Total Knee Replacement (TKR) Surgery with ATTUNE™ 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 Surgery with ATTUNE™ Knee Prosthesis by DePuy Receives: Device: ATTUNE™ 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, measured by means of RSA.
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
Measured: 2 Years
Secondary outcomes (4)
EQ-5D
General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire
Measured: 2 Years
KOOS
Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire
Measured: 2 Years
VAS pain
- Pain score after activity and during rest; (Likert scale 0-10)
Measured: 2 Years
2 Anchor questions
Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.
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 posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
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.
- More trials run by Leiden University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, DePuy International
- Responsible party
- Principal investigator, R.G.H.H. Nelissen, Leiden University Medical Center
- Investigators
- Rob G Nelissen, Prof. PhD, MD, Principal investigator, Dep. Orthopaedics, Leiden University Medical CenterEdward R Valstar, Prof. PhD. MSc, Principal investigator, Dep. Orthopaedics, Leiden University Medical CenterPeter H den Hollander, MD, Principal investigator, Dep. Orthopaedics, Medisch Centrum Haaglanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256098
- Sponsor's protocol ID
- P14.142
- Acronym
- APKnee
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. 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™ Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
- ClinicalTrials.gov ID
- NCT02256098
- Acronym / sponsor ID
- APKnee / P14.142
- Keywords
- Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-Up Studies, Arthroplasty, Replacement, Knee/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, DePuy International
- Study start
- Sep 2014 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 3 Oct 2014 (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.
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)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009).
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 (March 2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch 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 TKR 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. The tertiary objective of this study is to compare clinical and radiological outcome and PROMS of the prostheses with migration data.
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 TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The Hague, The Netherlands. Annually 300 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 of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (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™ Knee Prosthesis by DePuyTotal Knee Replacement Surgery with ATTUNE™ 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 or rheumatoid arthritis and requiring 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 (9 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
- 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™ Knee Prosthesis by DePuyTotal Knee Replacement (TKR) Surgery with ATTUNE™ 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, measured by means of RSA.
Time frame: 2 Years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
4 secondary outcomes
EQ-5D
Time frame: 2 Years
KOOS
Time frame: 2 Years
VAS pain
Time frame: 2 Years
2 Anchor questions
Time frame: 2 Years
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 1 Feb 2018.
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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.
Rob G Nelissen, Prof. PhD, MD principal investigator
Dep. Orthopaedics, Leiden University Medical Center
Edward R Valstar, Prof. PhD. MSc principal investigator
Dep. Orthopaedics, Leiden University Medical Center
Peter H den Hollander, MD principal investigator
Dep. Orthopaedics, Medisch Centrum Haaglanden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE™ Knee Prosthesis by DePuy and PFC Sigma Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Diseases, run by Leiden University Medical Center at 2 sites 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 9 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Migration, measured by means of 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 1 Feb 2018.