Systemic Metal Ion Concentrations in Patients with a PEEK HD coupling mechanism in the Modular Mega-prostheses of the Knee; a prospective cohort pilot study

*Systemic Metal Ion Concentrations in Patients with a PEEK HD coupling mechanism in the Modular Mega-prostheses of the Knee; a prospective cohort pilot study* - Metal-ions in patients with the PEEK HD coupling mechanism of the knee

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56747

Enrollment

Registered

2024-05-14

Start date

2025-02-03

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serum level of metal ions

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Serum metal ion concentrations Cobalt (Co) and Chrome (Cr) pre- and postoperatively (at 3-6, 12 and 24 months)	—

Secondary

Measure	Time frame
Secondary parameters are used to identify any adverse effects in patients with increased serum levels of ion metals (metallosis, osteolysis, periprosthetic loosening, pseudotumor formation). Tertiary parameters are used to identify possible risk factors correlating with metal-ion release. 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 to describe the study population.	—

Measure

Time frame

Secondary parameters are used to identify any adverse effects in patients with increased serum levels of ion metals (metallosis, osteolysis, periprosthetic loosening, pseudotumor formation). Tertiary parameters are used to identify possible risk factors correlating with metal-ion release. 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 to describe the study population.

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Countries

Netherlands

Outcome results