Retrospective Observational Cohort Study of SYMBOL CUP DM 2

Primary Total Hip Arthroplasty Clinical Trial

— SYMCOR-2  

Official title:

Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209426
• Other study ID #: SYMCOR-2
• Status: Completed
• Start date: March 18, 2015
• Est. completion date: August 13, 2018

Study information

• Verified date: December 2019
• Source: Dedienne Sante S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 13, 2018
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty
• Revision Total Hip Arthroplasty

Intervention

Device:
• THA with SYMBOL CUP DMR HA

• THA with SYMBOL CUP DM CEM

Locations

Country	Name	City	State
France	Hôpital Privé Medipole de Savoie	Challes les Eaux

Sponsors (1)

Lead Sponsor	Collaborator
Dedienne Sante S.A.S.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years as of index operation
Secondary	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
Secondary	Harris Hip Score (HHS) at baseline and 1-year follow-up	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	1 year as of index operation
Secondary	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. 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
Secondary	Devane classification at baseline, 1-year and 2-year follow-up	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	2 years as of index operation
Secondary	Charnley classification	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	2 years as of index operation