H-29 DELTA Multihole TT Study.

Study Overview
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Brief Summary
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This study is aimed to provide a clinical and radiographic evaluation of 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards.

Official Title
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A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA Multihole TT Acetabular Cup.

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: DELTA Multihole TT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards Age ≥ 18 years old Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC) Subjects able to comply with the protocol and to perform all scheduled follow-up visits Exclusion Criteria: Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use Age < 18 years old Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to: significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device. known metabolic disorders leading to progressive bone deterioration. Hip replacement on the contralateral side performed within less than one year. Female subjects 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DELTA Multihole TT|Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) | The percentage of subjects showing a Harris Hip Score (HHS) equal or greater than Good (i.e. equal or greater than 80 points) at 2 years after the surgery. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM measurement | Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery. | Pre-operative - Month 24 | 
| VAS Pain | Changes in the VAS Pain score from pre-operative (baseline) to 2 years after surgery. | Pre-operative - Month 24 | 
| Implant stability | Radiographic implant evaluation and stability assessment at 2 years after surgery. | Month 24 | 
| Survival rate | Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery | Month 24 | 
| Safety assessment | Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up. | Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24 |