Total Hip Arthroplasty
Conditions
Keywords
Cemented acetabular cup
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.
Interventions
DEVICEMueller cemented cups
Patients undergo total hip arthroplasty with the implant of Mueller cemented cups
Sponsors
Limacorporate S.p.a
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery | 2 years Follow up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical progression of HOOS up to 2 years FU, compared to the baseline | 6 weeks, 1 year and 2 years FU | 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 |
| Change in TUG from preoperative up to 2 years FU | 6 weeks, 1 year and 2 years FU | Timed Up and Go |
| Radiographic evaluation and stability assessment of the implant up to 2 years FU | 6 weeks, 1 year and 2 years FU | Radiographic stability, radiographically detectable complications |
| 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 | Adverse events and device deficiencies |
| Clinical progression of HHS up to 1 year FU, compared to the baseline | 6 weeks, 1 year | Harris Hip Score |
Countries
Italy
Outcome results
None listed