Cemented Acetabular Cups Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Device: Mueller cemented cups


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mueller cemented cups<br>Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component. | Device: Mueller cemented cups<br>* Patients undergo total hip arthroplasty with the implant of Mueller cemented cups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery | HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80 | 2 years Follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation and stability assessment of the implant up to 2 years FU |  | 6 weeks, 1 year and 2 years FU | 
| Clinical progression of HOOS up to 2 years FU, compared to the baseline | Hip disability and osteoarthritis outcome score (HOOS) is a patient-reported outcome measurement, that ranges from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms | 6 weeks, 1 year and 2 years FU | 
| Change in TUG from preoperative up to 2 years FU |  | 6 weeks, 1 year and 2 years FU | 
| Clinical progression of HHS up to 1 year FU, compared to the baseline |  | 6 weeks, 1 year | 
| Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery |  | 2 years FU | 
| Incidence of device-related AE/SAE up to 2 years of follow-up |  | 6 weeks, 1 year and 2 years FU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cemented acetabular cup