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

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Challes les Eaux, France, 73190
    • Hôpital Privé Medipole de Savoie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HMB-DMR-HA; 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.	Device: THA with SYMBOL CUP DMR HA
HMB-DM-CEM; 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.	Device: THA with SYMBOL CUP DM CEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival: Acetabular Cup Survival at 2-year Follow-up	This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint 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 acetabular 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
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
Harris Hip Score (HHS) at Baseline and 1-year Follow-up	Harris Hip Score (HHS) is measured at each assessment in each patient. HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability). 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. It consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points). Scores range from 0 (worse disability) to 91 (less disability)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

Collaborators and Investigators

• Sponsor: Dedienne Sante S.A.S.
• Investigators: Principal Investigator: Gilles Estour, M.D., Hôpital Privé Medipole de Savoie

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2015
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): August 14, 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): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: safety; total hip arthroplasty; efficacy; revision; complex; hemispherical dual-mobility acetabular cup; implant survival; prosthetic dislocation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Neurotransmitter Agents; Cholinergic Agents; Nootropic Agents; Parasympathomimetics; Cholinesterase Inhibitors; Tacrine
• Other Study ID Numbers: SYMCOR-2

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