Ospedale San Camillo di Trento
Trento, TN, 38122, Italy
NCT Number: NCT04831918
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Trento, TN, 38122, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Patients undergo total hip arthroplasty with the implant of Mueller cemented cups
Time frame: 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
Time frame: 6 weeks, 1 year and 2 years FU
Radiographic stability, radiographically detectable complications
Time frame: 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
Time frame: 6 weeks, 1 year and 2 years FU
Timed Up and Go
Time frame: 6 weeks, 1 year
Harris Hip Score
Time frame: 2 years FU
Time frame: 6 weeks, 1 year and 2 years FU
Adverse events and device deficiencies
Limacorporate S.p.a
Industry
A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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