Retrospective Observational Cohort Study of SYMBOL CUP DM 2

NCT04209426 | Completed Results

• 1 other identifier: SYMCOR-2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events

  2 years as of index operation

• Harris Hip Score (HHS) at Baseline and 1-year Follow-up

  1 year as of index operation

• The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up

  2 years as of index operation

Study Arms (2)

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

Interventions

THA with SYMBOL CUP DMR HA DEVICE

HMB-DMR-HA

THA with SYMBOL CUP DM CEM DEVICE

HMB-DM-CEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Exhaustive recruitment of patients meeting inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dedienne Sante S.A.S.: lead

Study Sites (1)

Hôpital Privé Medipole de Savoie

Challes-les-Eaux, 73190, France

Location

Results Point of Contact

• Title: Frederic C Daoud, M.D., M.Sc., Epidemiologist-Biostatistician
• Organization: Medextens SARL

fcdaoud@medextens.com

+33964281703

Study Officials

• Gilles Estour, M.D.

  Hôpital Privé Medipole de Savoie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: March 18, 2015
• Primary Completion: March 31, 2018
• Study Completion: August 14, 2018
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)