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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hip arthroplasty | Device | complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HHS score equal or greater than "Good" at 2 years after surgery | Month 24 |
| 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 |
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IInclusion criteria as per DELTA Multihole TT indications for use:
Age ≥ 18 years
If used in combination with spacers and hemispheric modules, other indications are:
Exclusion criteria as per DELTA Multihole TT contraindications for use:
Additional exclusion criteria:
• Female patients who are pregnant, nursing, or planning a pregnancy.
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Study participants will be selected from patients who underwent a Total Hip Arthroplasty with the DELTA Multihole TT cup. Both complex primary and revision cases are considered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boris Steno, MD PhD Prof | Contact | +421905512004 | bosten1@hotmail.com | |
| Ilja Chandoga, MD PhD | Contact | +421911643354 | chandoga@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Boris Steno, MD PhD Prof | University Hospital Bratislava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine | Recruiting | Bratislava | 85107 | Slovakia |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D012216 |
| Rheumatic Diseases |
| D004204 | Joint Dislocations |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |