Osteoarthritis ArthritisALKNEENCT03101007
RSA RCT: Attune RP TKA Versus LCS RP TKA
A study testing ATTUNE Knee Prosthesis by DePuy and LCS Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Disease, run by Spaarne Gasthuis at 2 sites in Netherlands.
Trial summary
The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable… 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 Knee Prosthesis by DePuy and LCS Knee Prosthesis by DePuy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Jul 2017to 5 Jun 2021
- 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 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.
- Status after patellectomy
- In case flexion is less than 90 degrees
- 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
- Patient is diagnosed with rheumatoid arthritis
- 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
Spaarne Gasthuis
Hoofddorp, 2130AT
Leiden University Medical Center
Leiden, 2300RC
About this study
Official title: A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM
The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates.
The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained.
Read more
The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates 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 Knee Prosthesis by DePuy, LCS Knee Prosthesis by DePuy
- Keywords
- Comparative study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-up studies, Arthroplast, Replacement, Knee/methods
- Medical subject headings
- Joint Diseases, Musculoskeletal 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 cementless ATTUNE rotating platform Knee Prosthesis by DePuy
LCS Knee Prosthesis by DePuyDevice
Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE | Experimental | Total Knee Replacement Surgery with cementless ATTUNE Rotating Platform Knee Prosthesis by DePuy Receives: Device: ATTUNE Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy |
| LCS | Active comparator | Total Knee Replacement Surgery with cementless LCS Rotating Platform Knee Prosthesis by DePuy Receives: Device: ATTUNE Knee Prosthesis by DePuy; Device: LCS 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 posted4 Apr 2017
- Study start25 Jul 2017
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Rob G Nelissen, Prof PhD MD, Principal investigator, Dep. Orthopaedics, Leiden University Medical CenterPeter A Nolte, PhD MD, Principal investigator, Dep. Orthopaedics, Spaarne GasthuisEdward R Valstar, Prof PhD Msc, Principal investigator, Dep. Orthopaedics, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101007
- Sponsor's protocol ID
- 2017.0027
- Acronym
- ALKNEE
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2017
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM
- ClinicalTrials.gov ID
- NCT03101007
- Acronym / sponsor ID
- ALKNEE / 2017.0027
- Keywords
- Comparative study, Knee Prosthesis, Prosthesis Design, Treatment Outcome, Follow-up studies, Arthroplast, Replacement, Knee/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 4 Apr 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.
The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates.
The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained.
The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates 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
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| ATTUNE | Experimental | Device: ATTUNE Knee Prosthesis by DePuy, Device: LCS Knee Prosthesis by DePuyTotal Knee Replacement Surgery with cementless ATTUNE Rotating Platform Knee Prosthesis by DePuy |
| LCS | Active comparator | Device: ATTUNE Knee Prosthesis by DePuy, Device: LCS Knee Prosthesis by DePuyTotal Knee Replacement Surgery with cementless LCS Rotating Platform 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 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 (8 listed)
- The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
- Status after patellectomy
- In case flexion is less than 90 degrees
- 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
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 cementless ATTUNE rotating platform Knee Prosthesis by DePuy | Device | ATTUNE, LCS |
| LCS Knee Prosthesis by DePuyTotal Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy | Device | ATTUNE, LCS |
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 27 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis Arthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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
Peter A Nolte, PhD MD principal investigator
Dep. Orthopaedics, Spaarne Gasthuis
Edward R Valstar, Prof PhD Msc principal investigator
Dep. Orthopaedics, Leiden University Medical Center
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 LCS Knee Prosthesis by DePuy in people with Osteoarthritis Arthritis and Joint Disease, run by Spaarne Gasthuis 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 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 27 Apr 2022.