Retrospective Observational Cohort Study of SYMBOL CUP DM 1

NCT04209374 | Completed

• 1 other identifier: SYMCOR-1
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Total Hip Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Devane classification at baseline, 1-year and 2-year follow-up.

  2 years as of index operation

• Charnley classification at baseline, 1-year and 2-year follow-up.

  2 years as of index operation

Study Arms (1)

HMB-DMR-HA

Primary total hip arthroplasty with hemispherical dual-mobility acetabular cup

Device: THA with SYMBOL CUP DM HA

Interventions

THA with SYMBOL CUP DM HA DEVICE

HMB-DMR-HA

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 DM HA
• 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)

Lyon Ortho Clinic - Clinique de la Sauvegarde

Lyon, 69009, France

Location

Study Officials

• Nicolas Bonin, M.D.

  Lyon Ortho Clinic - Clinique de la Sauvegarde

  PRINCIPAL INVESTIGATOR

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: July 3, 2014
• Primary Completion: December 17, 2015
• Study Completion: March 1, 2018
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)