Clinical trial · Observational
Metal-ions in Patients With the PEEK HD Coupling Mechanism of the Knee
Systemic Metal Ion Concentrations in Patients With a PEEK HD Coupling Mechanism in Modular Mega-prostheses of the Knee; a Prospective Cohort Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Knee Endoprosthesis | — | UNRESOLVED | — |
| Megaprosthesis | — | UNRESOLVED | — |
| Metal-ions | — | UNRESOLVED | — |
| Modular Universal Tumor And Revision System | — | UNRESOLVED | — |
| Mutars | — | UNRESOLVED | — |
| PEEK-HD Coupling Mechanism | — | UNRESOLVED | — |
| Tumor Prosthesis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism
- description
- This group consists of patients with a primary MUTARS knee endoprosthesis containing the PEEK-HD coupling mechanism.
- interventionNames
- Other: Blood sample analysis
- label
- Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism
- description
- 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.
- interventionNames
- Other: Blood sample analysis
Primary outcomes (1)
- measure
- Change in serum metal ion levels (Cobalt and Chrome)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: The patient 1. is 18 years of age or older 2. 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 3. Is able to give informed consent Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Anamnestic use of metal containing nutritional supplements or medications 2. Contact with metal ions in the work environment 3. Renal insufficiency defined as an eGFR\<60 4. Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)
References
Publications (0)
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