Primary Total Hip Arthroplasty Clinical Trial
— SYMCOR-2Official title:
Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2
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 |
Verified date | December 2019 |
Source | Dedienne Sante S.A.S. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Privé Medipole de Savoie | Challes les Eaux |
Lead Sponsor | Collaborator |
---|---|
Dedienne Sante S.A.S. |
France,
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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