Retrospective Observational Cohort Study of SYMBOL CUP DM 1 (SYMCOR-1)

Dedienne Sante

Status

Completed

Conditions

Primary Total Hip Arthroplasty

Treatments

Device: THA with SYMBOL CUP DM HA

Study type

Observational

Funder types

Industry

Identifiers

NCT04209374

SYMCOR-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients with total hip implant using hemispheric dual-mobility SYMBOL CUP DM HA
Operation performed by the primary investigator
Delay between index operation and March 1 2018 has reached 2 years

Exclusion criteria