NCT04209426

Retrospective Observational Cohort Study of SYMBOL CUP DM 2

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (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 total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.

Detailed description

Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) framework: Patients: \- Adult men and women requiring a total hip arthroplasty Intervention: \- THA with SYMBOL CUP DMR HA or SYMBOL CUP DM CEM hemispherical dual mobility acetabular implants. 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 (mHHS) 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 followups. Study design: * single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 2 years prior to study start. * Prospective 2-year follow-up letter and phone questionnaire.

Conditions

• Revision Total Hip Arthroplasty
• Primary Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	THA with SYMBOL CUP DMR HA
DEVICE	THA with SYMBOL CUP DM CEM

Timeline

• Start date: 2015-03-18
• Primary completion: 2018-03-31
• Completion: 2018-08-14
• First posted: 2019-12-24
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

1 site across 1 country: France