SYMCOR-2: Retrospective Observational Cohort Study of SYMBOL CUP DM 2

Sponsor

Dedienne Sante S.A.S. (Industry)

Overall Status

Completed

CT.gov ID

NCT04209426

Collaborator

(none)

Enrollment

Location

40.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 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.

Condition or Disease	Intervention/Treatment	Phase
Revision Total Hip Arthroplasty Primary Total Hip Arthroplasty	Device: THA with SYMBOL CUP DMR HA Device: THA with SYMBOL CUP DM CEM

Detailed Description

Description according to PICOS 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 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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2

Actual Study Start Date :

Mar 18, 2015

Actual Primary Completion Date :

Dec 13, 2016

Actual Study Completion Date :

Aug 13, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 number [2 years as of index operation]
This is a 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.

Secondary Outcome Measures

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]
All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery.
Harris Hip Score (HHS) at baseline and 1-year follow-up [1 year as of index operation]
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
The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up [2 years as of index operation]
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
Devane classification at baseline, 1-year and 2-year follow-up [2 years as of index operation]
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
Charnley classification [2 years as of index operation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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