Cemented Acetabular Cups Clinical Study

NCT ID: NCT04831918

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-01-31

Brief 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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mueller cemented cups

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

Group Type: EXPERIMENTAL

Mueller cemented cups

Intervention Type: DEVICE

Patients undergo total hip arthroplasty with the implant of Mueller cemented cups

Interventions

Mueller cemented cups

Patients undergo total hip arthroplasty with the implant of Mueller cemented cups

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Marega

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Camillo di Trento

Locations

Ospedale San Camillo di Trento

Trento, TN, Italy

Countries

Italy

Other Identifiers

H-31

Identifier Type: -

Identifier Source: org_study_id