Cemented Acetabular Cups Clinical Study

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    45
  • sponsor
    Limacorporate S.p.a
Updated on 31 July 2021
arthritis
avascular necrosis
hip arthroplasty
joint arthroplasty
joint disease

Summary

This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.

Details
Condition Total hip replacement, Hip Replacement, total hip arthroplasty
Treatment Mueller cemented cups
Clinical Study IdentifierNCT04831918
SponsorLimacorporate S.p.a
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee
The patient diagnosis is one or more of the following
Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis
Patient with avascular necrosis of the femoral head or fracture of the femoral neck
Patient with congenital or acquired deformity
Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty
The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet

Exclusion Criteria

The patient should be excluded from the study if he/she meets any of the
following criteria, which reflect the cemented acetabular cup contraindication
for use
Acute or chronic infections, local or systemic infections
Serious muscular, neurological or vascular diseases affecting the concerned limb
Any concomitant disease and dependence that might affect the implanted prosthesis
Allergy to material
Metal-on-metal systems: patients with renal impairment
Patient's age<18
Female patients who are pregnant, nursing, or planning a pregnancy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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