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This is a single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty with a SYMBOL CUP DM HA hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of that implant at two-year follow-up.
Description according to PICOS framework:
Patients:
- Adult men and women requiring a primary total hip arthroplasty
Intervention:
- Primary THA with SYMBOL CUP DM HA hemispherical dual mobility acetabular implant.
Comparator: None
Outcomes:
Study design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMB-DMR-HA | Primary total hip arthroplasty with hemispherical dual-mobility acetabular cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THA with SYMBOL CUP DM HA | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival: Ratio of the number of participants alive with the complete index hip prosthesis in position at 2-year follow-up, over their initial numberprosthesis in position at 2-year follow-up, over their initial number. | This is the ratio of the number of participants who are alive with the complete index hip prosthesis in position at a given follow-up time (numerator) over the initial number of those participants from the date they received the index hip prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each participant index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the hip prosthesis in place. The longest duration between the index operation and the final assessment is 2 years. | 2 years as of index operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events | All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery | 2 years as of index operation |
| Harris Hip Score (HHS) at baseline and 1-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Exhaustive recruitment of patients meeting inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Bonin, M.D. | Lyon Ortho Clinic - Clinique de la Sauvegarde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyon Ortho Clinic - Clinique de la Sauvegarde | Lyon | 69009 | France |
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The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments |
| 1 year as of index operation |
| The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up | The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments | 2 years as of index operation |
| Devane classification at baseline, 1-year and 2-year follow-up. | The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments | 2 years as of index operation |
| Charnley classification at baseline, 1-year and 2-year follow-up. | The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments | 2 years as of index operation |