Wear of Articular Bearing Surface of Prosthetic JointCS vs CR RSANCT05936593
Migration of CS vs CR Insert in TKA Using RSA
A study testing Condylar Stabilizing (CS) insert and Cruciate Retaining (CR) insert in people with Wear of Articular Bearing Surface of Prosthetic Joint and Migration of Implant, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial summary
Background: The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wear of Articular Bearing Surface of Prosthetic Joint, Migration of Implant
- What is being tested?
- Condylar Stabilizing (CS) insert and Cruciate Retaining (CR) insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jul 2023to Jun 2035
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo primary total knee replacement with the MAKO-robotic arm, with one of the following indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
- One or more compartments are involved;
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability (meaning a varus, valgus or flexion deformity < 15 degrees);
- Age between 18 and 70 years;
- ASA score I or II;
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- A good nutritional state of the patient;
- Patients with a completely intact PCL at the time of surgery;
- Patient is able to understand the study and is willing to participate and to sign the Informed Consent;
- Patient is able to speak and write Dutch.
Who cannot join
- Contraindications manufacturer:
- Any active or suspected latent infection in or about the knee joint;
- Distant foci of infection which may cause hematogenous spread to the implant site;
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care;
- Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis;
- Skeletal immaturity;
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- Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function;
- Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan;
- Body Mass Index (BMI) of > 35 kg/m2;
- Flexion contracture of 15 degrees and more;
- Varus/valgus contracture of 15 degrees and more;
- History of total or unicompartmental reconstruction of the affected joint;
- Bilateral operation;
- A Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study);
- A Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study);
- Patients who will need lower limb joint replacement for another joint within one year.
- Active or suspected latent infection in or about the knee joint;
- Osteomyelitis;
- Sepsis;
- A systemic or metabolic disorder leading to progressive bone deterioration, excluding rheumatoid arthritis;
- Vascular insufficiency, muscular atrophy;
- Neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device;
- Female patients planning a pregnancy during the course of the study;
- The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis;
- A knee fusion to the affected joint;
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, 2725 NA
J. Pasma, 079 - 206 5595, Onderzoek@rhoc.nl
About this study
Official title: Migration in a Cruciate Retaining and a Condylar Stabilizing Insert of a Robot-assisted Uncemented Total Knee Prosthesis Using Model-based RSA: a Mono-Center Randomized Controlled Trial With 10 Years Follow-up
Background:
The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert.
Read more
To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before.
Objective:
The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and usability of the tantalum markers and the marker inserter will be determined. The secondary objective is to determine the influence of the type of insert on the wear, inducible displacement, survival and clinical outcomes.
Study design:
A randomized controlled trial
Study population:
Forty-four patients scheduled to undergo primary total knee replacement, aged below 70 years with an ASA-score of 1 or 2 will be needed in total, divided in two groups of 22 patients each.
Intervention:
One group receives an uncemented TKP with a CS insert, while the other group receives an uncemented TKP with a CR insert. Both will be placed using the MAKO-robotic arm using a kinematic balancing technique.
Outcomes:
Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively.
- Being tested
- Condylar Stabilizing (CS) insert, Cruciate Retaining (CR) insert
- Keywords
- Total knee arthroplasty, Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condylar Stabilizing (CS) insertDevice
During TKA surgery a Condylar Stabilizing (CS) insert is implanted and tantalum beads are placed around the prosthesis.
Cruciate Retaining (CR) insertDevice
During TKA surgery a Cruciate Retaining (CR) insert is implanted and tantalum beads are placed around the prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Condylar Stabilizing (CS) insert | Active comparator | Not described Receives: Device: Condylar Stabilizing (CS) insert |
| Cruciate Retaining (CR) insert | Active comparator | Not described Receives: Device: Cruciate Retaining (CR) insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translations (mm)
The translations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.
Measured: 10 years after surgery
Rotations (degrees)
The rotations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.
Measured: 10 years after surgery
Stability of the tantalum markers
Stability of the tantalum markers will be determined by the mean error value of the markers.
Measured: 10 years after surgery
Safety of the tantalum markers and the inserter
Safety of the tantalum markers are determined by registration of the complications due to the markers and/or marker inserter. Complications will be expressed by numbers and percentages.
Measured: 10 years after surgery
Secondary outcomes (11)
Wear
Wear of the insert measures in 3 axis (x, y and z)
Measured: 10 years after surgery
Inducible displacement (mm)
The inducible displacement gives insight into the nature and durability of the fixation and is defined as the micromotion occurring in response to external forces. The inducible displacement will be expressed by translations (x-, y- and z-direction) in mm
Measured: 10 years after surgery
Inducible displacement (degrees)
The inducible displacement gives insight into the nature and durability of the fixation and is defined as the micromotion occurring in response to external forces. The inducible displacement will be expressed by rotations (x-, y- and z-direction) in degrees.
Measured: 10 years after surgery
Survival
Survival of the CS and CR inserts is measured by registration of all complications and is expressed by numbers and percentages.
Measured: 10 years after surgery
Clinical outcomes: Knee Society Score (KSS)
The Knee Society Score (KSS) is a questionnaire to rate the knee prosthesis function. A high score means a good function and a low score means a worse function. The score varies between 0 and 100.
Measured: 10 years after surgery
Clinical outcomes: Numeric Rating Scale for pain (NRS pain)
The Numeric Pain Rating Scale (NRS) measures the amount of pain experienced in the past week during rest and activity. It is a scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: 10 years after surgery
Clinical outcomes: EuroQol 5D (EQ-5D-5L)
The EuroQol-5D-5L (EQ-5D-5L) is a questionnaire that describes the overall health condition of the person. The score is given by an index consisting of 5 numbers, which represents a health status. A lower score indicates a good condition. The last question of this questionnaire is the overall health condition of the person on a scale of 0 to 100. In this question a higher score indicates a good condition.
Measured: 10 years after surgery
Clinical outcomes: Knee Injury and Osteoarthritis Outcome Score (short version, KOOS-PS)
The Knee Injury and Osteoarthritis Outcome Score - short version (KOOS-PS) is a questionnaire about the ability to perform normal daily activities. A high score means that the activities cost a lot of effort to perform, while a low score means that the activities can be done with minimum effort. The score varies between 0 and 100.
Measured: 10 years after surgery
Clinical outcomes: Forgotten Joint Score (FJS)
The Forgotten Joint score (FJS) is a questionnaire about the awareness of the prosthetic knee. A high score means a low awareness and a low score means a high awareness. The score varies between 0 and 100.
Measured: 10 years after surgery
Clinical outcomes: Numeric Rating Scale for Satisfaction (NRS satisfaction)
The satisfaction is a single question about the overall satisfaction of the result of the surgery on a scale from 0 (very unsatisfied) to 10 (very satisfied).
Measured: 10 years after surgery
Clinical outcomes: Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a questionnaire about the amount of influence of the operated knee on the persons life. A low score means that the life of the person is influenced a lot by the operated knee, while a high score means that the life of the persons is little influenced by the operated knee. The score varies between 0 and 48.
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start21 Jul 2023
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear of Articular Bearing Surface of Prosthetic JointStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936593
- Sponsor's protocol ID
- OC-2021-004
- Acronym
- CS vs CR RSA
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration in a Cruciate Retaining and a Condylar Stabilizing Insert of a Robot-assisted Uncemented Total Knee Prosthesis Using Model-based RSA: a Mono-Center Randomized Controlled Trial With 10 Years Follow-up
- ClinicalTrials.gov ID
- NCT05936593
- Acronym / sponsor ID
- CS vs CR RSA / OC-2021-004
- Keywords
- Total knee arthroplasty, Insert
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Jun 2035 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 10 Jul 2023 (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.
Background:
The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert.
To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before.
Objective:
The primary objective is to compare the migration of both the femoral and tibial component by the use of a CS insert or CR insert both made of HXPLE using model-based roentgen stereophotogrammetric analysis (mRSA). Furthermore, the safety and usability of the tantalum markers and the marker inserter will be determined. The secondary objective is to determine the influence of the type of insert on the wear, inducible displacement, survival and clinical outcomes.
Study design:
A randomized controlled trial
Study population:
Forty-four patients scheduled to undergo primary total knee replacement, aged below 70 years with an ASA-score of 1 or 2 will be needed in total, divided in two groups of 22 patients each.
Intervention:
One group receives an uncemented TKP with a CS insert, while the other group receives an uncemented TKP with a CR insert. Both will be placed using the MAKO-robotic arm using a kinematic balancing technique.
Outcomes:
Main study parameters are migration of the femoral and tibial components measured with model-based RSA software till 10 years postoperatively. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or the marker inserter will be registered. The secondary parameters are wear, inducible displacement, survival, clinical outcomes and complications up to 10 years postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condylar Stabilizing (CS) insert | Active comparator | Device: Condylar Stabilizing (CS) insert |
| Cruciate Retaining (CR) insert | Active comparator | Device: Cruciate Retaining (CR) insert |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients scheduled to undergo primary total knee replacement with the MAKO-robotic arm, with one of the following indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
- One or more compartments are involved;
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability (meaning a varus, valgus or flexion deformity < 15 degrees);
- Age between 18 and 70 years;
Key exclusion criteria (27 listed)
- Contraindications manufacturer:
- Any active or suspected latent infection in or about the knee joint;
- Distant foci of infection which may cause hematogenous spread to the implant site;
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care;
- Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis;
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 |
|---|---|---|
| Condylar Stabilizing (CS) insertDuring TKA surgery a Condylar Stabilizing (CS) insert is implanted and tantalum beads are placed around the prosthesis. | Device | Condylar Stabilizing (CS) insert |
| Cruciate Retaining (CR) insertDuring TKA surgery a Cruciate Retaining (CR) insert is implanted and tantalum beads are placed around the prosthesis. | Device | Cruciate Retaining (CR) insert |
Primary outcome
Translations (mm)
Time frame: 10 years after surgery
The translations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.
Rotations (degrees)
Time frame: 10 years after surgery
The rotations of the femoral and tibial components measured in 3 axis (z, y and z) with model-based RSA over 10 years.
Stability of the tantalum markers
Time frame: 10 years after surgery
Stability of the tantalum markers will be determined by the mean error value of the markers.
Safety of the tantalum markers and the inserter
Time frame: 10 years after surgery
Safety of the tantalum markers are determined by registration of the complications due to the markers and/or marker inserter. Complications will be expressed by numbers and percentages.
11 secondary outcomes
Wear
Time frame: 10 years after surgery
Inducible displacement (mm)
Time frame: 10 years after surgery
Inducible displacement (degrees)
Time frame: 10 years after surgery
Survival
Time frame: 10 years after surgery
Clinical outcomes: Knee Society Score (KSS)
Time frame: 10 years after surgery
Clinical outcomes: Numeric Rating Scale for pain (NRS pain)
Time frame: 10 years after surgery
Clinical outcomes: EuroQol 5D (EQ-5D-5L)
Time frame: 10 years after surgery
Clinical outcomes: Knee Injury and Osteoarthritis Outcome Score (short version, KOOS-PS)
Time frame: 10 years after surgery
Clinical outcomes: Forgotten Joint Score (FJS)
Time frame: 10 years after surgery
Clinical outcomes: Numeric Rating Scale for Satisfaction (NRS satisfaction)
Time frame: 10 years after surgery
Clinical outcomes: Oxford Knee Score (OKS)
Time frame: 10 years after surgery
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 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condylar Stabilizing (CS) insert and Cruciate Retaining (CR) insert in people with Wear of Articular Bearing Surface of Prosthetic Joint and Migration of Implant, run by Reinier Haga Orthopedisch Centrum 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 10 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 18 Dec 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?
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?
Contact J. Pasma (079 - 206 5595, Onderzoek@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translations (mm) (time frame: 10 years after surgery). The study lists 4 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 Dec 2023.