Health TrialsbyHealthPanel

A Post Market Surveillance Study About the MONOCER Cup

ConditionTotal Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedacta International SA

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use

Patients who have signed the informed consent to participate in the study

Disqualifiers

Minor patients, patients over 75 years of age at the time of primary surgery;

Any patient who is unable or unwilling to give informed consent to participate in the study.

Trial population

Patients listed for a Total Hip Arthroplasty (THA) with Mpact 3D Metal MONOCER cup, meeting all inclusion/exclusion criteria, at the research site, will be proposed to take part to the current study during the preoperative visit. The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mpact 3D metal MONOCER cup

    Device

    adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Assessment of implant survivorship using Kaplan Meier curve

a Kaplan Meir survival curve will be calcuated

Time frame
10 years

Secondary outcomes

1

Assessment of Device stability throught a radiological exam

standard x-ray examination will be peformed during the visits

Time frame
6 months, 1 year, 5 and 10 years
2

Assessment of the clinical outcome following total hip replacement using the Harris Hip score

HHS score will be completed

Time frame
6 months, 1 year, 5 and 10 years
3

Device Safety assessed through adverse event collection

number of adverse event occurred

Time frame
up to 10 yrs follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medacta International SA

Lead sponsor

Source ClinicalTrials.gov
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