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Retrospective Observational Cohort Study of SYMBOL CUP DM 2 — SYMCOR-2  

Primary Total Hip Arthroplasty Clinical Trial

Official title:
Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2

Clinical Trial Summary

This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 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.

Clinical Trial Description

Description according to PICOS 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04209426
Study type Observational
Source Dedienne Sante S.A.S.
Contact
Status Completed
Phase
Start date March 18, 2015
Completion date August 13, 2018
View Details
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