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

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1

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.

Study Overview

• Status: Completed
• Conditions: Primary Total Hip Arthroplasty
• Intervention / Treatment: Device: THA with SYMBOL CUP DM HA

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.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Lyon Ortho Clinic - Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Exhaustive recruitment of patients meeting inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HMB-DMR-HA; Primary total hip arthroplasty with hemispherical dual-mobility acetabular cup	Device: THA with SYMBOL CUP DM HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This is the ratio of the number of participants who are alive with the complete index hip prosthesis in position at a given follow-up time (numerator) over the initial number of those participants from the date they received the index hip prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each participant index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the hip prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.	2 years as of index operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS) at baseline and 1-year follow-up	The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments	1 year as of index operation
The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up	The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments	2 years as of index operation
Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events	All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery	2 years as of index operation
Devane classification at baseline, 1-year and 2-year follow-up.	The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments	2 years as of index operation
Charnley classification at baseline, 1-year and 2-year follow-up.	The class is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments	2 years as of index operation

Collaborators and Investigators

• Sponsor: Dedienne Sante S.A.S.
• Investigators: Principal Investigator: Nicolas Bonin, M.D., Lyon Ortho Clinic - Clinique de la Sauvegarde

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2014
• Primary Completion (ACTUAL): December 17, 2015
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: safety; efficacy; primary total hip arthroplasty; hemispherical dual-mobility acetabular cup; implant survival; prosthetic dislocation; Harris hip score HHS
• Other Study ID Numbers: SYMCOR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No