N/A
N=20
Retrospective Observational Cohort Study of SYMBOL CUP DM 2
Revision Total Hip Arthroplasty · Primary Total Hip Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT04209426 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Apr 2025
Primary outcome: Primary: Implant Survival: Acetabular Cup Survival at 2-year Follow-up — 94.7; 100 percentage of implants survival
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- THA with SYMBOL CUP DMR HA (Device); THA with SYMBOL CUP DM CEM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dedienne Sante S.A.S.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival: Acetabular Cup Survival at 2-year Follow-up |
94.7; 100 | — |
| SECONDARY Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events |
10; 0 | — |
| SECONDARY Harris Hip Score (HHS) at Baseline and 1-year Follow-up |
34; 58; 89; 86 | — |
| SECONDARY The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up |
29; 49; 80; 77; 87; 80 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04209426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.