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

Conditions: Serum level of metal ions
10023213
10072990
10005944

Registration Number: NL-OMON56747

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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 ml/min
4) Presence of implants containing Cobalt and Chrome (including non-orthopaedic
implants such as stents and dental implants)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum metal ion concentrations Cobalt (Co) and Chrome (Cr) pre- and<br /><br>postoperatively (at 3-6, 12 and 24 months)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are used to identify any adverse effects in patients with<br /><br>increased serum levels of ion metals (metallosis, osteolysis, periprosthetic<br /><br>loosening, pseudotumor formation).<br /><br><br /><br>Tertiary parameters are used to identify possible risk factors correlating with<br /><br>metal-ion release.<br /><br><br /><br>Quaternary parameters (PROMIS 29 or TESS) are used to evaluate the functional<br /><br>outcome of the patient. All other variables (e.g. general baseline<br /><br>characteristics, treatment characteristics, and surgical details including<br /><br>prosthesis details) will be gathered to describe the study population.</p><br>