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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Patients undergo total hip arthroplasty with the implant of Mueller cemented cups
Ospedale San Camillo di Trento
Trento, TN, Italy
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
Time frame: 2 years Follow up
Radiographic evaluation and stability assessment of the implant up to 2 years FU
Radiographic stability, radiographically detectable complications
Time frame: 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
Time frame: 6 weeks, 1 year and 2 years FU
Change in TUG from preoperative up to 2 years FU
Timed Up and Go
Time frame: 6 weeks, 1 year and 2 years FU
Clinical progression of HHS up to 1 year FU, compared to the baseline
Harris Hip Score
Time frame: 6 weeks, 1 year
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery
Time frame: 2 years FU
Incidence of device-related AE/SAE up to 2 years of follow-up
Adverse events and device deficiencies
Time frame: 6 weeks, 1 year and 2 years FU
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