Primary Total Hip Arthroplasty Clinical Trial
Official title:
Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1
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:
- Safety 1: Implant survival over 2-year follow-up.
- Safety 2: All adverse events, with focus on implant dislocation, infections, revision
surgery
- Efficacy 1: Harris Hip Score (HHS) at baseline and 1-year follow-up.
- Efficacy 2: Modified HHS consisting of pain + functional subscores at baseline, 1-year
and 2-year follow-ups.
- Efficacy 2: Devane score at baseline, 1-year and 2-year follow-ups.
- Efficacy 3: Charnley classification at baseline, 1-year and 2-year follow-ups.
Study design:
- single-center retrospective observational cohort study of consecutively operated
patients who underwent primary total hip arthroplasty 2 years prior to study start.
- Prospective 2-year follow-up letter and phone questionnaire.
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