MedDataX Logo

Retrospective Observational Cohort Study of SYMBOL CUP DM 1

NCT ID: NCT04209374

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-03

Study Completion Date

2018-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Total Hip Arthroplasty

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

primary total hip arthroplasty hemispherical dual-mobility acetabular cup safety efficacy implant survival prosthetic dislocation Harris hip score HHS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HMB-DMR-HA

Primary total hip arthroplasty with hemispherical dual-mobility acetabular cup

THA with SYMBOL CUP DM HA

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THA with SYMBOL CUP DM HA

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dedienne Sante S.A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicolas Bonin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lyon Ortho Clinic - Clinique de la Sauvegarde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lyon Ortho Clinic - Clinique de la Sauvegarde

Lyon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SYMCOR-1

Identifier Type: -

Identifier Source: org_study_id