Metal-ions in Patients With the PEEK HD Coupling Mechanism of the Knee

NCT05893602 | Not Yet Recruiting

• 1 other identifier: NL82185.058.22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mutars; Modular Universal Tumor And Revision System; Metal-ions; Tumor Prosthesis; Megaprosthesis; PEEK-HD Coupling Mechanism; Knee Endoprosthesis

Outcome Measures

Primary Outcomes (1)

• Change in serum metal ion levels (Cobalt and Chrome)

  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.

  24 months

Secondary Outcomes (1)

• Adverse effects

  24 months

Study Arms (2)

Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism

This group consists of patients with a primary MUTARS knee endoprosthesis containing the PEEK-HD coupling mechanism.

Other: Blood sample analysis

Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism

This group consists of patients requiring revision surgery of their MUTARS knee endoprosthesis containing the MoM coupling mechanism (for any reason), which is exchanged/revised for the PEEK-HD coupling mechanism.

Other: Blood sample analysis

Interventions

Blood sample analysis OTHER

Blood sample analysis on Cobalt and Chrome will be performed during the period under study.

Primary tumor prosthesis of the knee containing the PEEK HD coupling mechanism; Revision tumor prosthesis of the knee containing the PEEK-HD coupling mechanism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be drawn from the outpatient clinic of the orthopaedic surgery in the Leiden University Medical Center (LUMC). Starting from January 2023, all patients with an indication for a mega-prosthesis of the knee, will receive a PEEK HD coupling mechanism primarily or in case of a revision procedure (if clinically possible) after replacing the MoM coupling mechanism. Patients will be screened for eligibility by the orthopaedic surgeon. After the patient is deemed eligible, he/she will be informed about this study and asked for participation.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Central Study Contacts

Richard Evenhuis, Drs.

CONTACT

0651672659; r.e.evenhuis@lumc.nl

Michiel van de Sande, Prof.

CONTACT

m.a.j.van_de_sande@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michiel AJ van de Sande, MD, PhD

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

NL (1)