Objective: We aim to 1) monitor and investigate the change in serum metal ion (Cobalt and Chrome) levels postoperatively (at 3-6, 12 and 24 months) in patients receiving a primary PEEK HD coupling mechanism, monitor and investigate the change in…
ID
Source
Brief title
Condition
- Joint disorders
- Soft tissue neoplasms malignant and unspecified
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum metal ion concentrations Cobalt (Co) and Chrome (Cr) pre- and
postoperatively (at 3-6, 12 and 24 months)
Secondary outcome
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.
Background summary
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, we have recently encountered a number of early
mechanical failures of these MoM coupling mechanisms. 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, we will switch to the use of the new (approved and
CE-marked) PEEK HD coupling mechanism. We hypothesize that the PEEK HD coupling
mechanism will not result in elevated serum metal ion levels in patients
receiving a mega prosthesis.
Study objective
Objective: We aim to 1) monitor and investigate the change in serum metal ion
(Cobalt and Chrome) levels postoperatively (at 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 (at 0,
3-6, 12 and 24 months) 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 burden and risks
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.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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)
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 |
|---|---|
| Other | NL82185.058.22 |
| CCMO | NL82185.058.24 |