NCT04209374

Retrospective Observational Cohort Study of SYMBOL CUP DM 1

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Dedienne Sante S.A.S. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	THA with SYMBOL CUP DM HA

Timeline

• Start date: 2014-07-03
• Primary completion: 2015-12-17
• Completion: 2018-03-01
• First posted: 2019-12-24
• Last updated: 2019-12-30

Locations

1 site across 1 country: France