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This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G7 G7 Acetabular System | All patients will receive G7 G7 Acetabular System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G7 Acetabular System | Device | All patients will receive G7 Acetabular System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant dislocation rate | Dislocation is defined as the complete loss of articulation contact between two artificial joint components. | One year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Functional Performance by Oxford Hip Score | The Oxford Hip score consist of 12 disease-specific questions measuring patient-reported pain and function of the hip joint. Responses to each question are formatted as a 5-point Likert scale, scored from 0 (the worst outcome/most symptoms) to 4 (the best outcome / least symptoms). The scores for each question are added together for a final result between 0 and 48. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.
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| Name | Affiliation | Role |
|---|---|---|
| Kee-Hyung Rhyu | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea | |||
| Hanyang University Medical Center |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Up to 5 years post-surgery |
| Implant survivorship by revision rates | Cumulative survival rates using a Kaplan-Meier analysis. | Up to 5 years post-surgery |
| Quality of life by EQ-5D-5L questionnaire | This 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The health states may be converted into a single index value where 1 represents full health and 0 represents death. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Up to 5 years post-surgery |
| Quality of life by JHEQ | The Japanese Orthopaedic Association hip disease evaluation questionnaire (JHEQ) is a self-administered questionnaire that evaluates the quality of life in patients with hip disease. The questionnaire consists of three subscales: pain (28 points), movement (28 points), and mental (28 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only. | Up to 5 years post-surgery |
| Pain and Functional Performance by JOA Hip Score | The Japanese Orthopaedic Association (JOA) hip score consists of four subcategories: pain (Pain, 40 points), range of motion (ROM, 20 points), ability to walk (Gait, 20 points), and activities of daily life (ADL, 20 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only. | Up to 5 years post-surgery |
| Adverse events reported | Summary of adverse events by category, incidence and frequency | Up to 5 years post-surgery |
| Seoul |
| 04763 |
| South Korea |
| Asan medical Centre | Seoul | 05505 | South Korea |
| Seoul National University Bundang Hospital | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| KyungHee University Medical Center | Seoul | 130-872 | South Korea |
| D007869 |
| Leg Injuries |