Retrospective Observational Cohort Study of SYMBOL CUP DM 2 (SYMCOR-2)

Dedienne Sante

Status: Completed

Conditions: Primary Total Hip Arthroplasty; Revision Total Hip Arthroplasty

Treatments: Device: THA with SYMBOL CUP DMR HA; Device: THA with SYMBOL CUP DM CEM

Study type: Observational

Funder types: Industry

Identifiers

NCT04209426

SYMCOR-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 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 DMR HA or SYMBOL CUP DM CEM
• Operation performed by the primary investigator
• Delay between index operation and March 1 2018 has reached 2 years

Exclusion criteria

• patient refusal to participate in the study
• minors (age < 18 years)
• patients under guardianship

Trial design

20 participants in 2 patient groups

HMB-DMR-HA

Description:

Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a hydroxyapatite-coated outer surface as well as two pegs and one screw.

Treatment:

Device: THA with SYMBOL CUP DMR HA

HMB-DM-CEM

Description:

Total hip arthroplasty with hemispherical metal-back dual-mobility acetabular cup with tripod fixation consisting of a bare metal outer surface to be covered with bone-compatible cement.

Treatment:

Device: THA with SYMBOL CUP DM CEM