H-28 DELTA ST-C and Minima Retrospective Study.

Study Overview
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Brief Summary
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The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.

Official Title
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A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: DELTA-ST cup in combination with MINIMA stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards Both genders Any race A diagnosis in the target hip of one or more of the following: Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis Rheumatoid Arthritis Post-traumatic arthritis Fractures of femoral neck Congenital or acquired deformity Patient willingness to participate Exclusion Criteria: Local or systemic infection Septicaemia Persistent acute or chronic osteomyelitis Confirmed nerve or muscle lesion compromising hip joint function Vascular or nerve diseases affecting the concerned limb Poor bone stock (for example due to osteoporosis) compromising the stability of the implant Metabolic disorders which may impair fixation and stability of the implant Any concomitant disease and dependence that might affect the implanted prosthesis Metal hypersensitivity to implant materials Required revision of previous standard femoral stem 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

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-ST cup in combination with MINIMA stem|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) | Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery | Pre-operative - Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability assessment of DELTA ST-C cup | Radiographic analysis and stability assessment of the DELTA ST-C cup as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up | At discharge - Month 36 | 
| Stability assessment of MINIMA stem | Radiographic analysis and stability assessment of the MINIMA stem as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up | At discharge - Month 36 | 
| Survival rate of the implant | The survival rate of the implant is expressed by Kaplan-Meier estimator | Month 36 | 
| Safety assessment (adverse events) | Assessment of any possible adverse device event or device-related complication detected and recorded | Intra-operative - Month 36 |