MutarsMIONSNCT05893602
Metal-ions in Patients With the PEEK HD Coupling Mechanism of the Knee
An observational study of Mutars and Modular Universal Tumor And Revision System, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this observational study is to evaluate the changes of serum metal ion (Cobalt and Chrome) levels at 0, 3-6, 12, and 24 months postoperative in patients receiving a MUTARS mega-prostheses of the knee with a PEEK HD coupling mechanism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mutars, Modular Universal Tumor And Revision System, Metal-ions
- What is being tested?
- Blood sample analysis
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2023to Jun 2028
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects will be drawn from the outpatient clinic of the orthopaedic surgery in the Leiden University Medical Center (LUMC). Starting from January 2023, all patients with an indication for a mega-prosthesis of the knee, will receive a PEEK HD coupling mechanism primarily or in case of a revision procedure (if clinically possible) after replacing the MoM coupling mechanism. Patients will be screened for eligibility by the orthopaedic surgeon. After the patient is deemed eligible, he/she will be informed about this study and asked for participation.
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
- is 18 years of age or older
- receives a MUTARS knee replacement with PEEK HD coupling mechanism, or undergoes a revision (for any reason) of a MUTARS knee replacement during which the MoM coupling mechanism is revised for a PEEK HD coupling mechanism
- Is able to give informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Anamnestic use of metal containing nutritional supplements or medications
- Contact with metal ions in the work environment
- Renal insufficiency defined as an eGFR<60
- Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michiel van de Sande, Prof. contact
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Richard Evenhuis, Drs., 0651672659, r.e.evenhuis@lumc.nl
Michiel van de Sande, Prof., m.a.j.van_de_sande@lumc.nl
About this study
Official title: Systemic Metal Ion Concentrations in Patients With a PEEK HD Coupling Mechanism in Modular Mega-prostheses of the Knee; a Prospective Cohort Pilot Study
The goal of this observational study is to evaluate the changes of serum metal ion (Cobalt and Chrome) levels at 0, 3-6, 12, and 24 months postoperative in patients receiving a MUTARS mega-prostheses of the knee with a PEEK HD coupling mechanism. The main question(s) to answer are: • [what is the change in serum level metal ions (Cobalt and Chrome) in patients receiving a primary MUTARS knee endoprosthesis with the PEEK HD coupling mechanism ] • [what is the change in serum level metal ions (Cobalt and Chrome) in patients with a MoM coupling mechanism revised to the PEEK HD coupling mechanism]. Participants will be asked to fill out functional outcome measures during the period under study.
Read the detailed description
Rationale:
Local release of metal ions and their systemic sequelae is an increasing source of concern in patients with an endoprosthetic reconstruction of major joints. It is assumed that metal-on-metal (MoM) articulations, used in several types of mega-prostheses, may cause release of metal ions. Corrosion of non-articulating surfaces, abrasive wear of soft tissues and fretting of modular junctions could contribute to this release. The release of metal ions are known to induce inflammatory responses and immune reactions in the directly exposed tissues and can cause serious local adverse reactions such as metallosis, osteolysis, pseudotumor formation and systemic adverse effects such as cardiovascular and neurological adverse effects. Our study group previously found significantly elevated serum levels of Silver (Ag), Chrome (Cr) and Cobalt (Co) in a series (not published yet) of 11 patients with a MoM coupling mechanism of knee endoprostheses. Furthermore, a number of early mechanical failures of these MoM coupling mechanisms were encountered by the investigators recently.
The implant manufacturer (ImplantCast GmbH) recently introduced a carbon-reinforced PEEK HD (polyether ether ketone high demand) coupling mechanism in an attempt to reduce the risk of early mechanical failure and to lower the risk on the release of metal ions. Based on the outcomes of previous research and the mechanical failures of the MoM coupling mechanism, the investigating center will switch to the use of the new (approved and CE-marked) PEEK HD coupling mechanism. Hypothesized is that the PEEK HD coupling mechanism will not result in elevated serum metal ion levels in patients receiving a mega prosthesis.
Objective:
The aim is to 1) monitor and investigate the change in serum metal ion (Cobalt and Chrome) levels postoperatively (at 0, 3-6, 12 and 24 months) in patients receiving a primary PEEK HD coupling mechanism, monitor and investigate the change in serum metal ion levels pre-and postoperatively in patients with an MoM coupling mechanism which is revised to a PEEK HD coupling mechanism (in case of failure for any reason), 2) document adverse effects caused by metal ions, 3) report factors (possibly) correlating with metal ion release and 4) evaluate the functional outcome of the patient using the Patient-Reported Outcome Measurement Information System (PROMIS) 29 and or Toronto Extremity Salvage Score (TESS) lower extremity.
Study design:
This is a prospective cohort pilot study to evaluate metal ion concentrations, possible adverse effects and functional outcomes after the implantation of a PEEK HD coupling mechanism.
Study population:
Patients ≥18 years receiving a reconstruction with a MUTARS knee endoprosthesis (distal femur, proximal tibia or total knee) with a PEEK HD couplingmechanism, and patients receiving a PEEK HD coupling mechanism in the case of a revision procedure of a MUTARS knee endoprosthesis with a MoM coupling mechanism.
Main study parameters/endpoints:
(1) Serum metal ion concentrations Cobalt (Co) and Chrome (Cr) pre- and postoperatively (at 3-6, 12 and 24 months), (2) Secondary parameters are used to identify any adverse effects in patients with increased serum levels of ion metals (metallosis, osteolysis, periprosthetic loosening, pseudotumor formation). (3) Tertiary parameters are used to identify possible risk factors correlating with metal-ion release. (4) quaternary parameters (PROMIS 29 or TESS) are used to evaluate the functional outcome of the patient. All other variables (e.g. general baseline characteristics, treatment characteristics, and surgical details including prosthesis details) will be gathered within the "MORE" cohort study and "biobank" study (study number 2022-031, reference BWD005/SH/sh).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Serum metal ion concentrations (Cobalt and Chrome) will be determined at 0, 3-6, 12, and 24 months postoperatively. The potential benefits of routine determination of metal ion concentrations are early detection of toxic values of metal ions. Except for the negligible risks of routine venepuncture no potential risks are anticipated.
- Conditions
- Mutars, Modular Universal Tumor And Revision System, Metal-ions, Tumor Prosthesis, Megaprosthesis, PEEK-HD Coupling Mechanism
- Being tested
- Blood sample analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample analysisOther
Blood sample analysis on Cobalt and Chrome will be performed during the period under study.
| Study group | Role | What they receive |
|---|---|---|
| Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism | This group consists of patients with a primary MUTARS knee endoprosthesis containing the PEEK-HD coupling mechanism. Receives: Other: Blood sample analysis | |
| Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism | This group consists of patients requiring revision surgery of their MUTARS knee endoprosthesis containing the MoM coupling mechanism (for any reason), which is exchanged/revised for the PEEK-HD coupling mechanism. Receives: Other: Blood sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum metal ion levels (Cobalt and Chrome)
Main study parameter are the change in serum metal ion levels (Cobalt/Chrome) in patients receiving the PEEK HD coupling mechanism in a MUTARS knee mega prosthesis.
Serum metal ion levels will be obtained postoperative (at 3-6, 12 and 24 months) of patients receiving a primary MUTARS knee mega prosthesis with the PEEK HD coupling mechanism. Furthermore, serum metal ion levels will be determined pre- and postoperatively (0, 3-6, 12 and 24 months) in patients requiring revision surgery of the MoM coupling mechanism (for any reason) which is exchanged for the PEEK HD coupling mechanism.
Measured: 24 months
Secondary outcomes (1)
Adverse effects
Secondary endpoint is the emergence of adverse effects. No solid evidence for expected adverse effects is available. Therefore patients will be screened for local and systemic adverse events. No invasive examinations for low incidence adverse effects will be performed. X-rays will be performed according to standard care and are assessed for mechanical failure, osteolysis and loosening. Depending on the indication for the primary procedure (e.g. tumor type), additional imaging will be performed according to standard follow-up protocols. In case of a malignant bone tumor, magnetic resonance imaging (MRI) will be performed at one and two year follow-up to assess (pseudo)tumor formation/recurrence.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MutarsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel AJ van de sande, MD, PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893602
- Sponsor's protocol ID
- NL82185.058.22
- Acronym
- MIONS
- Status last verified
- Jun 2023
- First submitted
- 21 Apr 2023
- Last updated
- 8 Jun 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Metal Ion Concentrations in Patients With a PEEK HD Coupling Mechanism in Modular Mega-prostheses of the Knee; a Prospective Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT05893602
- Acronym / sponsor ID
- MIONS / NL82185.058.22
- Conditions
- Mutars, Modular Universal Tumor And Revision System, Metal-ions, Tumor Prosthesis, Megaprosthesis, PEEK-HD Coupling Mechanism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Jun 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.
The goal of this observational study is to evaluate the changes of serum metal ion (Cobalt and Chrome) levels at 0, 3-6, 12, and 24 months postoperative in patients receiving a MUTARS mega-prostheses of the knee with a PEEK HD coupling mechanism. The main question(s) to answer are: • [what is the change in serum level metal ions (Cobalt and Chrome) in patients receiving a primary MUTARS knee endoprosthesis with the PEEK HD coupling mechanism ] • [what is the change in serum level metal ions (Cobalt and Chrome) in patients with a MoM coupling mechanism revised to the PEEK HD coupling mechanism]. Participants will be asked to fill out functional outcome measures during the period under study.
Detailed description
Rationale:
Local release of metal ions and their systemic sequelae is an increasing source of concern in patients with an endoprosthetic reconstruction of major joints. It is assumed that metal-on-metal (MoM) articulations, used in several types of mega-prostheses, may cause release of metal ions. Corrosion of non-articulating surfaces, abrasive wear of soft tissues and fretting of modular junctions could contribute to this release. The release of metal ions are known to induce inflammatory responses and immune reactions in the directly exposed tissues and can cause serious local adverse reactions such as metallosis, osteolysis, pseudotumor formation and systemic adverse effects such as cardiovascular and neurological adverse effects. Our study group previously found significantly elevated serum levels of Silver (Ag), Chrome (Cr) and Cobalt (Co) in a series (not published yet) of 11 patients with a MoM coupling mechanism of knee endoprostheses. Furthermore, a number of early mechanical failures of these MoM coupling mechanisms were encountered by the investigators recently.
The implant manufacturer (ImplantCast GmbH) recently introduced a carbon-reinforced PEEK HD (polyether ether ketone high demand) coupling mechanism in an attempt to reduce the risk of early mechanical failure and to lower the risk on the release of metal ions. Based on the outcomes of previous research and the mechanical failures of the MoM coupling mechanism, the investigating center will switch to the use of the new (approved and CE-marked) PEEK HD coupling mechanism. Hypothesized is that the PEEK HD coupling mechanism will not result in elevated serum metal ion levels in patients receiving a mega prosthesis.
Objective:
The aim is to 1) monitor and investigate the change in serum metal ion (Cobalt and Chrome) levels postoperatively (at 0, 3-6, 12 and 24 months) in patients receiving a primary PEEK HD coupling mechanism, monitor and investigate the change in serum metal ion levels pre-and postoperatively in patients with an MoM coupling mechanism which is revised to a PEEK HD coupling mechanism (in case of failure for any reason), 2) document adverse effects caused by metal ions, 3) report factors (possibly) correlating with metal ion release and 4) evaluate the functional outcome of the patient using the Patient-Reported Outcome Measurement Information System (PROMIS) 29 and or Toronto Extremity Salvage Score (TESS) lower extremity.
Study design:
This is a prospective cohort pilot study to evaluate metal ion concentrations, possible adverse effects and functional outcomes after the implantation of a PEEK HD coupling mechanism.
Study population:
Patients ≥18 years receiving a reconstruction with a MUTARS knee endoprosthesis (distal femur, proximal tibia or total knee) with a PEEK HD couplingmechanism, and patients receiving a PEEK HD coupling mechanism in the case of a revision procedure of a MUTARS knee endoprosthesis with a MoM coupling mechanism.
Main study parameters/endpoints:
(1) Serum metal ion concentrations Cobalt (Co) and Chrome (Cr) pre- and postoperatively (at 3-6, 12 and 24 months), (2) Secondary parameters are used to identify any adverse effects in patients with increased serum levels of ion metals (metallosis, osteolysis, periprosthetic loosening, pseudotumor formation). (3) Tertiary parameters are used to identify possible risk factors correlating with metal-ion release. (4) quaternary parameters (PROMIS 29 or TESS) are used to evaluate the functional outcome of the patient. All other variables (e.g. general baseline characteristics, treatment characteristics, and surgical details including prosthesis details) will be gathered within the "MORE" cohort study and "biobank" study (study number 2022-031, reference BWD005/SH/sh).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Serum metal ion concentrations (Cobalt and Chrome) will be determined at 0, 3-6, 12, and 24 months postoperatively. The potential benefits of routine determination of metal ion concentrations are early detection of toxic values of metal ions. Except for the negligible risks of routine venepuncture no potential risks are anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism | – | Other: Blood sample analysisThis group consists of patients with a primary MUTARS knee endoprosthesis containing the PEEK-HD coupling mechanism. |
| Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism | – | Other: Blood sample analysisThis group consists of patients requiring revision surgery of their MUTARS knee endoprosthesis containing the MoM coupling mechanism (for any reason), which is exchanged/revised for the PEEK-HD coupling mechanism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects will be drawn from the outpatient clinic of the orthopaedic surgery in the Leiden University Medical Center (LUMC). Starting from January 2023, all patients with an indication for a mega-prosthesis of the knee, will receive a PEEK HD coupling mechanism primarily or in case of a revision procedure (if clinically possible) after replacing the MoM coupling mechanism. Patients will be screened for eligibility by the orthopaedic surgeon. After the patient is deemed eligible, he/she will be informed about this study and asked for participation.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: The patient
- is 18 years of age or older
- receives a MUTARS knee replacement with PEEK HD coupling mechanism, or undergoes a revision (for any reason) of a MUTARS knee replacement during which the MoM coupling mechanism is revised for a PEEK HD coupling mechanism
- Is able to give informed consent
Key exclusion criteria (5 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Anamnestic use of metal containing nutritional supplements or medications
- Contact with metal ions in the work environment
- Renal insufficiency defined as an eGFR<60
- Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)
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 |
|---|---|---|
| Blood sample analysisBlood sample analysis on Cobalt and Chrome will be performed during the period under study. | Other | Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism, Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism |
Primary outcome
Change in serum metal ion levels (Cobalt and Chrome)
Time frame: 24 months
Main study parameter are the change in serum metal ion levels (Cobalt/Chrome) in patients receiving the PEEK HD coupling mechanism in a MUTARS knee mega prosthesis. Serum metal ion levels will be obtained postoperative (at 3-6, 12 and 24 months) of patients receiving a primary MUTARS knee mega prosthesis with the PEEK HD coupling mechanism. Furthermore, serum metal ion levels will be determined pre- and postoperatively (0, 3-6, 12 and 24 months) in patients requiring revision surgery of the MoM coupling mechanism (for any reason) which is exchanged for the PEEK HD coupling mechanism.
1 secondary outcome
Adverse effects
Time frame: 24 months
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 8 Jun 2023.
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.
Michiel van de Sande, Prof. contact
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 Mutars and Modular Universal Tumor And Revision System, run by Leiden University Medical Center 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Jun 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 Richard Evenhuis, Drs. (0651672659, r.e.evenhuis@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum metal ion levels (Cobalt and Chrome) (time frame: 24 months). 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 8 Jun 2023.