Clinical trial NCT04209374: Retrospective Observational Cohort Study of SYMBOL CUP DM 1
Official title: Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Total Hip Arthroplasty
Keywords: primary total hip arthroplasty
hemispherical dual-mobility acetabular cup
safety
efficacy
implant survival
prosthetic dislocation
Harris hip score HHS
Lead sponsor: Dedienne Sante S.A.S.
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exhaustive recruitment of patients meeting inclusion and exclusion criteria

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Implant survival: Ratio of the number of participants alive with the complete index hip prosthesis in position at 2-year follow-up, over their initial numberprosthesis in position at 2-year follow-up, over their initial number.
timeFrame: 2 years as of index operation
Secondary outcomes:
measure: Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events
timeFrame: 2 years as of index operation
measure: Harris Hip Score (HHS) at baseline and 1-year follow-up
timeFrame: 1 year as of index operation
measure: The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up
timeFrame: 2 years as of index operation
measure: Devane classification at baseline, 1-year and 2-year follow-up.
timeFrame: 2 years as of index operation
measure: Charnley classification at baseline, 1-year and 2-year follow-up.
timeFrame: 2 years as of index operation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Lyon Ortho Clinic - Clinique de la Sauvegarde
Study officials:
affiliation: Lyon Ortho Clinic - Clinique de la Sauvegarde
name: Nicolas Bonin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: