NCT05785364 A Post Market Surveillance Study About the MONOCER Cup
| NCT ID | NCT05785364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Total Hip Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-01-25 |
| Primary Completion | 2050-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-01-25 with a primary completion date of 2050-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.
Eligibility Criteria
Inclusion Criteria: 1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use 2. Patients who have signed the informed consent to participate in the study Exclusion Criteria: 1. Minor patients, patients over 75 years of age at the time of primary surgery; 2. Any patient who is unable or unwilling to give informed consent to participate in the study.
Contact & Investigator
Placido Bartolone, Dr
PRINCIPAL INVESTIGATOR
Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève
Frequently Asked Questions
Who can join the NCT05785364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05785364 currently recruiting?
Yes, NCT05785364 is actively recruiting participants. Contact the research team at bonacina@medacta.ch for enrollment information.
Where is the NCT05785364 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05785364 clinical trial?
NCT05785364 is sponsored by Medacta International SA. The principal investigator is Placido Bartolone, Dr at Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève. The trial plans to enroll 250 participants.