Primary Total Hip ArthroplastySYMCOR-1NCT04209374
Retrospective Observational Cohort Study of SYMBOL CUP DM 1
An observational study of Primary Total Hip Arthroplasty, run by Dedienne Sante S.A.S. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- THA with SYMBOL CUP DM HA
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2014to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exhaustive recruitment of patients meeting inclusion and exclusion criteria
Who may be able to join
- 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
Who cannot join
- patient refusal to participate in the study
- minors (age < 18 years)
- patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1
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.
Read the detailed description
Description according to PICOS framework:
Patients:
- Adult men and women requiring a primary total hip arthroplasty
Intervention:
- Primary THA with SYMBOL CUP DM HA hemispherical dual mobility acetabular implant.
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 follow-ups.
Study design:
- single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty 2 years prior to study start.
- Prospective 2-year follow-up letter and phone questionnaire.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- THA with SYMBOL CUP DM HA
- Keywords
- primary total hip arthroplasty, hemispherical dual-mobility acetabular cup, safety, efficacy, implant survival, prosthetic dislocation, Harris hip score HHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA with SYMBOL CUP DM HADevice
| Study group | Role | What they receive |
|---|---|---|
| HMB-DMR-HA | Primary total hip arthroplasty with hemispherical dual-mobility acetabular cup Receives: Device: THA with SYMBOL CUP DM HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery
Measured: 2 years as of index operation
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
Measured: 1 year as of index operation
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
Measured: 2 years as of index operation
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
Measured: 2 years as of index operation
Charnley 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
Measured: 2 years as of index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start3 Jul 2014
- Primary completion17 Dec 2015
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dedienne Sante S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Bonin, M.D., Principal investigator, Lyon Ortho Clinic - Clinique de la Sauvegarde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209374
- Sponsor's protocol ID
- SYMCOR-1
- Acronym
- SYMCOR-1
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1
- ClinicalTrials.gov ID
- NCT04209374
- Acronym / sponsor ID
- SYMCOR-1 / SYMCOR-1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dedienne Sante S.A.S.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- 17 Dec 2015 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Description according to PICOS framework:
Patients:
- Adult men and women requiring a primary total hip arthroplasty
Intervention:
- Primary THA with SYMBOL CUP DM HA hemispherical dual mobility acetabular implant.
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 follow-ups.
Study design:
- single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty 2 years prior to study start.
- Prospective 2-year follow-up letter and phone questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMB-DMR-HA | – | Device: THA with SYMBOL CUP DM HAPrimary total hip arthroplasty with hemispherical dual-mobility acetabular cup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exhaustive recruitment of patients meeting inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- patient refusal to participate in the study
- minors (age < 18 years)
- patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THA with SYMBOL CUP DM HA | Device | HMB-DMR-HA |
Primary outcome
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.
Time frame: 2 years as of index operation
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.
5 secondary outcomes
Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events
Time frame: 2 years as of index operation
Harris Hip Score (HHS) at baseline and 1-year follow-up
Time frame: 1 year as of index operation
The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up
Time frame: 2 years as of index operation
Devane classification at baseline, 1-year and 2-year follow-up.
Time frame: 2 years as of index operation
Charnley classification at baseline, 1-year and 2-year follow-up.
Time frame: 2 years as of index operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Bonin, M.D. principal investigator
Lyon Ortho Clinic - Clinique de la Sauvegarde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Total Hip Arthroplasty, run by Dedienne Sante S.A.S. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years as of index operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.