Cemented Acetabular Cups Clinical Study

Limacorporate

Status: Completed

Conditions: Total Hip Arthroplasty

Treatments: Device: Mueller cemented cups

Study type: Interventional

Funder types: Industry

Identifiers

NCT04831918

H-31

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;

2. 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.

3. 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:

1. Acute or chronic infections, local or systemic infections;
2. Serious muscular, neurological or vascular diseases affecting the concerned limb;
3. Any concomitant disease and dependence that might affect the implanted prosthesis;
4. Allergy to material;
5. Metal-on-metal systems: patients with renal impairment.
6. Patient's age<18
7. Female patients who are pregnant, nursing, or planning a pregnancy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Mueller cemented cups

Experimental group

Description:

Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component.

Treatment:

Device: Mueller cemented cups