Systemic Metal Ion Concentrations in Patients With a PEEK HD Coupling Mechanism in Modular Mega-prostheses of the Knee; a Prospective Cohort Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in serum metal ion levels (Cobalt and Chrome)
Study Overview
Brief Summary
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.
Detailed Description
Rationale:
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, a number of early mechanical failures of these MoM coupling mechanisms were encountered by the investigators recently.
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, the investigating center will switch to the use of the new (approved and CE-marked) PEEK HD coupling mechanism. Hypothesized is that the PEEK HD coupling mechanism will not result in elevated serum metal ion levels in patients receiving a mega prosthesis.
Objective:
The aim is to 1) monitor and investigate the change in serum metal ion (Cobalt and Chrome) levels postoperatively (at 0, 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 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: The patient
- •is 18 years of age or older
- •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
- •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:
- •Anamnestic use of metal containing nutritional supplements or medications
- •Contact with metal ions in the work environment
- •Renal insufficiency defined as an eGFR<60
- •Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)
Outcomes
Primary Outcomes
Change in serum metal ion levels (Cobalt and Chrome)
Time Frame: 24 months
Main study parameter are the change in serum metal ion levels (Cobalt/Chrome) in patients receiving the PEEK HD coupling mechanism in a MUTARS knee mega prosthesis. Serum metal ion levels will be obtained postoperative (at 3-6, 12 and 24 months) of patients receiving a primary MUTARS knee mega prosthesis with the PEEK HD coupling mechanism. Furthermore, serum metal ion levels will be determined pre- and postoperatively (0, 3-6, 12 and 24 months) in patients requiring revision surgery of the MoM coupling mechanism (for any reason) which is exchanged for the PEEK HD coupling mechanism.
Secondary Outcomes
- Adverse effects(24 months)
Investigators
Michiel AJ van de sande, MD, PhD
Michiel AJ van de Sande, MD, PhD
Leiden University Medical Center