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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04209426
Other study ID # SYMCOR-2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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