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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mueller cemented cups | Experimental | Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mueller cemented cups | Device | Patients undergo total hip arthroplasty with the implant of Mueller cemented cups |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation and stability assessment of the implant up to 2 years FU | Radiographic stability, radiographically detectable complications | 6 weeks, 1 year and 2 years FU |
| Clinical progression of HOOS up to 2 years FU, compared to the baseline |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Marega | Ospedale San Camillo di Trento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Camillo di Trento | Trento | TN | 38122 | Italy |
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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 | Timed Up and Go | 6 weeks, 1 year and 2 years FU |
| Clinical progression of HHS up to 1 year FU, compared to the baseline | Harris Hip Score | 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 | Adverse events and device deficiencies | 6 weeks, 1 year and 2 years FU |