DELTA Multihole TT Study

Study Overview
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Brief Summary
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A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

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

Conditions
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Hip Osteoarthritis, Arthroplasty Complications, Hip Dysplasia

Intervention / Treatment
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* Device: hip arthroplasty


Participation Criteria
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Eligibility Criteria
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IInclusion criteria as per DELTA Multihole TT indications for use: Age ≥ 18 years Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis; Signed Informed consent Hip dislocation using protruded liners, spacers; Rheumatoid arthritis; Post-traumatic arthritis; Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion; Fractures of femoral neck; If used in combination with spacers and hemispheric modules, other indications are: Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results; Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum. Exclusion criteria as per DELTA Multihole TT contraindications for use: Local or systemic infections; 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 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. Additional exclusion criteria: • Female patients 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: hip arthroplasty|complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of HHS score equal or greater than Good at 2 years after surgery |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic implant evaluation and stability assessment | Migration over 2 mm or over 5 degrees | Week 6, Week 12, Month 6, Month 12, Month 24 | 
| Survival rate | Kaplan-Meier | Month 24 | 
| Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L). | The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). | Month 24 | 
| Incidence of device-related Adverse Events / Serious Adverse Events |  | Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, hip arthroplasty revision, complex primary arthroplasty, trabecular titanium