Clinical trial NCT04209426: Retrospective Observational Cohort Study of SYMBOL CUP DM 2
Official title: Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Revision Total Hip Arthroplasty
Primary Total Hip Arthroplasty
Keywords: total hip arthroplasty
complex
revision
hemispherical dual-mobility acetabular cup
safety
efficacy
implant survival
prosthetic dislocation
Lead sponsor: Dedienne Sante S.A.S.
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 20
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 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.

Detailed 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.

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

Primary outcomes:
measure: Implant Survival: Acetabular Cup Survival at 2-year Follow-up
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
Other outcomes:
Locations:
city: Challes les Eaux
country: France
facility: Hôpital Privé Medipole de Savoie
Study officials:
affiliation: Hôpital Privé Medipole de Savoie
name: Gilles Estour, M.D.
role: PRINCIPAL_INVESTIGATOR
References: