Total Knee ArthroplastyNCT05623215
ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System
An observational study of Total Knee Arthroplasty and Total Knee Replacement, run by Spaarne Gasthuis at 1 site in Netherlands.
Trial summary
The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Replacement, Knee Osteoarthritis
- What is being tested?
- Radiographs of the knee for radiostereometric analysis (RSA)
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Nov 2022to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In this study, all subjects that participated in the initial study (ALknee study - NL58911.058.16) will be asked to participate. All these patients underwent a TKA for symptomatic osteoarthritis of the knee in the period of August 2017 and March 2018 at the Department of Orthopaedics in the Spaarne Gasthuis, Hoofddorp, The Netherlands.
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- The Patient participated in the initial study (NL58911.058.16) [1].
- The patient is capable of giving informed consent and expressing a willingness to comply with the study.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- The patient underwent a major revision TKR (exchange of the tibial or femoral component).
- The patient is unable or unwilling to sign the informed consent specific to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Migration and Inducible Displacement Through RSA of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System; A Clinical Randomized Controlled RSA Follow-up Study
The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary.
The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.
- Being tested
- Radiographs of the knee for radiostereometric analysis (RSA)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographs of the knee for radiostereometric analysis (RSA)Radiation
RSA radiographs will be made 5 and 10 years after the total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Cementless ATTUNE | Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System Receives: Radiation: Radiographs of the knee for radiostereometric analysis (RSA) | |
| Cementless LCS | Cementless LCS rotating platform Cruciate Sacrificing Knee System Receives: Radiation: Radiographs of the knee for radiostereometric analysis (RSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline migration of the prostheses
Migration is measured and expressed in translations, rotations, and MTPM; MTPM is the point of the prosthesis that has moved most.
Measured: 5 years post TKA
Ten year change from baseline migration of the prostheses
Migration is measured and expressed in translations, rotations and MTPM; MTPM is the point of the prosthesis that has moved most.
Measured: 10 years post TKA
Secondary outcomes (14)
Inducible displacement
The inducible displacement is defined as the difference in translation (MTPM) between a measurement without external force (e.g., supine position) and a measurement with external force (e.g., weight bearing) minus the measurement error.
Measured: 5 years post TKA
Inducible displacement
The inducible displacement is defined as the difference in translation (MTPM) between a measurement without external force (e.g., supine position) and a measurement with external force (e.g., weight bearing) minus the measurement error.
Measured: 10 years post TKA
EuroQol 5D-5L (EQ-5D-5L)
A patient reported outcome score for assessing mental well-being by using a score from 0 to 1, with 0 = worse and 1 = best.
Measured: 5 year post TKA
EuroQol 5D-5L (EQ-5D-5L)
A patient reported outcome score for assessing mental well-being by using a score from 0 to 1, with 0 = worse and 1 = best.
Measured: 10 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
A 7-item patient reported outcome score that measures daily physical functioning by using a score of 0 to 100, with 0 = no problems and 100 = extreme problems.
Measured: 5 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
A 7-item patient reported outcome score that measures daily physical functioning by using a score of 0 to 100, with 0 = no problems and 100 = extreme problems.
Measured: 10 year post TKA
Oxford-12 Knee Score (OKS)
A 12-item patient-reported outcome score to assess function and pain after total knee arthroplasty. The score uses a score of 0 to 48, with 0 = worse and 48 = best.
Measured: 5 year post TKA
Oxford-12 Knee Score (OKS)
A 12-item patient-reported outcome score to assess function and pain after total knee arthroplasty. The score uses a score of 0 to 48, with 0 = worse and 48 = best.
Measured: 10 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)
A 13-item patient reported outcome score for assessing daily anterior knee pain, by using a score from 0 to 100, with 0 = having anterior knee pain with disabilities and 100 = no signs of anterior knee pain.
Measured: 5 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)
A 13-item patient reported outcome score for assessing daily anterior knee pain, by using a score from 0 to 100, with 0 = having anterior knee pain with disabilities and 100 = no signs of anterior knee pain.
Measured: 10 year post TKA
Numeric Rating Scale (NRS)
A patient reported outcome score for assessing pain by using a likert scale from 0 to 10, with 0 = no pain and 10 = severe pain)
Measured: 5 year post TKA
Numeric Rating Scale (NRS)
A patient reported outcome score for assessing pain by using a likert scale from 0 to 10, with 0 = no pain and 10 = severe pain)
Measured: 10 year post TKA
Anchor questions
A patient reported outcome score for assessing change in functioning and pain since surgery.
The outcome is evaluated by use of a likert scale from 1 to 7, with 1 = much deteriorated and 7 = much improved).
Measured: 5 year post TKA
Anchor questions
A patient reported outcome score for assessing change in functioning and pain since surgery.
The outcome is evaluated by use of a likert scale from 1 to 7, with 1 = much deteriorated and 7 = much improved).
Measured: 10 year post TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start10 Nov 2022
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Raymond Puijk, Spaarne Gasthuis
- Investigators
- Peter A. Nolte, Prof. MD, Principal investigator, Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623215
- Sponsor's protocol ID
- NL82000.058.22
- Status last verified
- Apr 2024
- First submitted
- 3 Nov 2022
- Last updated
- 18 Apr 2024
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Migration and Inducible Displacement Through RSA of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System; A Clinical Randomized Controlled RSA Follow-up Study
- ClinicalTrials.gov ID
- NCT05623215
- Acronym / sponsor ID
- NL82000.058.22
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 21 Nov 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 cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary.
The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cementless ATTUNE | – | Radiation: Radiographs of the knee for radiostereometric analysis (RSA)Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System |
| Cementless LCS | – | Radiation: Radiographs of the knee for radiostereometric analysis (RSA)Cementless LCS rotating platform Cruciate Sacrificing Knee System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, all subjects that participated in the initial study (ALknee study - NL58911.058.16) will be asked to participate. All these patients underwent a TKA for symptomatic osteoarthritis of the knee in the period of August 2017 and March 2018 at the Department of Orthopaedics in the Spaarne Gasthuis, Hoofddorp, The Netherlands.
Key inclusion criteria (3 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- The Patient participated in the initial study (NL58911.058.16) [1].
- The patient is capable of giving informed consent and expressing a willingness to comply with the study.
Key exclusion criteria (3 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- The patient underwent a major revision TKR (exchange of the tibial or femoral component).
- The patient is unable or unwilling to sign the informed consent specific to this study.
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 |
|---|---|---|
| Radiographs of the knee for radiostereometric analysis (RSA)RSA radiographs will be made 5 and 10 years after the total knee arthroplasty. | Radiation | Cementless ATTUNE, Cementless LCS |
Primary outcome
Change from baseline migration of the prostheses
Time frame: 5 years post TKA
Migration is measured and expressed in translations, rotations, and MTPM; MTPM is the point of the prosthesis that has moved most.
Ten year change from baseline migration of the prostheses
Time frame: 10 years post TKA
Migration is measured and expressed in translations, rotations and MTPM; MTPM is the point of the prosthesis that has moved most.
14 secondary outcomes
Inducible displacement
Time frame: 5 years post TKA
Inducible displacement
Time frame: 10 years post TKA
EuroQol 5D-5L (EQ-5D-5L)
Time frame: 5 year post TKA
EuroQol 5D-5L (EQ-5D-5L)
Time frame: 10 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
Time frame: 5 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
Time frame: 10 year post TKA
Oxford-12 Knee Score (OKS)
Time frame: 5 year post TKA
Oxford-12 Knee Score (OKS)
Time frame: 10 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)
Time frame: 5 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)
Time frame: 10 year post TKA
Numeric Rating Scale (NRS)
Time frame: 5 year post TKA
Numeric Rating Scale (NRS)
Time frame: 10 year post TKA
Anchor questions
Time frame: 5 year post TKA
Anchor questions
Time frame: 10 year post TKA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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 A. Nolte, Prof. MD principal investigator
Spaarne Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Total Knee Replacement, run by Spaarne Gasthuis 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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline migration of the prostheses (time frame: 5 years post TKA). 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 18 Apr 2024.