(1) We aim to quantify systemic metal ion concentrations ions (Ag/Co/Cr/Mo/Ti/Al/V) before and after megaprosthesis arthroplasty in blood serum, (2) identify factors correlated to ion release in megaprostheses, (3) document adverse effects caused by…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Serum metal ion concentrations of Silver (Ag), Cobalt (Co), Chrome (Cr),
Molybdenum (Mo), Titanium (Ti), Aluminium (Al), Vanadium (V) during follow up.
Secondary outcome
(1) Adverse effects (metallosis, osteolysis, periprosthetic loosening,
pseudotumour formation and argyria) (2) Quality of life and functional status
using SF-36 and TESS.
Background summary
Systemic and local release of metal ions in endoprosthesis arthroplasty is an
increasing source of concern. It is assumed that release of metal ions is
caused by metal-on-metal articulations used in several types of megaprostheses.
However, corrosion of non-articulating surfaces, abrasive wear of soft tissues
and fretting of modular junctions could contribute to release of metal ions. In
addition; silver coatings have been developed to purposefully release silver
metal ions in the case of an infection.
Release of metal ions is known to induce inflammatory responses and immune
reactions in the directly exposed tissues. In literature serious local adverse
reactions such as metallosis, osteolysis, and pseudotumor formation are
reported.
Systemic exposure to metal ions in blood serum has been demonstrated in
metal-on-metal prostheses as well as in megaprostheses. What adverse effects
emerge, as a result of systemic metal ion dissemination, is not fully known. In
the case of cobaltism, mainly cardiovascular and neurological adverse effects
are reported. Silver ions are reported to cause argyria, neuropathy, hepatic
and renal failure. Little solid data is published concerning adverse effects,
especially in the case of high metal ion concentrations of Chrome, Molybdenum,
Titanium, Aluminium and Vanadium.
Since mid and long-term prospective data on metal ion dissemination in
megaprostheses is lacking, we will perform a prospective study to investigate
metal ion concentrations before and after megaprostheses implantation. Because
a large proportion of adverse effects associated with high systemic metal ion
concentrations overlap with adverse effects associated with chemotherapy
emphasis will be laid on local adverse effects.
Study objective
(1) We aim to quantify systemic metal ion concentrations ions
(Ag/Co/Cr/Mo/Ti/Al/V) before and after megaprosthesis arthroplasty in blood
serum, (2) identify factors correlated to ion release in megaprostheses, (3)
document adverse effects caused by metal ions.
Study design
This study is a prospective cohort study to evaluate metal ion concentrations,
factors correlated to metal ion release and adverse effects after
megaprosthesis implantation.
Study burden and risks
All patients participating in this study will be asked to visit the outpatient
clinic at 12 weeks, 12 months, and then annually up to 5 years postoperatively
to determine serum metal ion concentrations (Ag/Co/Cr/Mo/Ti/Al/V). X-ray
imaging will be performed. Patients will be asked to fill out quality of life
and functional status questionnaires (SF-36 and TESS). Magnetic resonance
imaging (MARS sequence) will be performed at the annual follow up points.
Outpatient visits, questionnaires, blood sampling, x-ray and magnetic resonance
examinations can be seen as a part of routine patient care. Potential benefits
of routine determination of metal ion concentrations could be early detection
of toxic values of metal ions. Except for the negligible risks of routine
venepuncture no potential risks are anticipated.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
-Males and females, 18 years of age or older
-Primary treatment by endoprosthetic reconstruction with a MUTARS modular megaprosthesis (all types of MUTARS, including expandable prostheses, are acceptable)
-Provision of informed consent
Exclusion criteria
-Revision surgery of any type of metallic prosthesis
-Anamnestic use of metal containing nutritional supplements or medications
-Contact with metal ions in the work environment
-Renal insufficiency defined as an eGFR<60
-Patient refusal to participate in the study
-Likely problems, in the judgement of the investigator, with maintaining follow-up
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61035.058.17 |