Revision Total Hip ArthroplastySYMCOR-2NCT04209426
Retrospective Observational Cohort Study of SYMBOL CUP DM 2
An observational study of Revision Total Hip Arthroplasty and 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 total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Hip Arthroplasty, Primary Total Hip Arthroplasty
- What is being tested?
- THA with SYMBOL CUP DMR HA and THA with SYMBOL CUP DM CEM
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2015to 14 Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
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 2
This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) 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.
Read the detailed description
Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) 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 (mHHS) 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.
- Being tested
- THA with SYMBOL CUP DMR HA, THA with SYMBOL CUP DM CEM
- Keywords
- total hip arthroplasty, complex, revision, hemispherical dual-mobility acetabular cup, safety, efficacy, implant survival, prosthetic dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA with SYMBOL CUP DMR HADevice
THA with SYMBOL CUP DM CEMDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: THA with SYMBOL CUP DM CEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival: Acetabular Cup Survival at 2-year Follow-up
This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint 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 acetabular 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 (3)
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
Harris Hip Score (HHS) is measured at each assessment in each patient. HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability).
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. It consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points). Scores range from 0 (worse disability) to 91 (less disability)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
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 start18 Mar 2015
- Primary completion31 Mar 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Revision 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dedienne Sante S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles Estour, M.D., Principal investigator, Hôpital Privé Medipole de Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209426
- Sponsor's protocol ID
- SYMCOR-2
- Acronym
- SYMCOR-2
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2019
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2
- ClinicalTrials.gov ID
- NCT04209426
- Acronym / sponsor ID
- SYMCOR-2 / SYMCOR-2
- Keywords
- total hip arthroplasty, complex, revision, hemispherical dual-mobility acetabular cup, safety, efficacy, implant survival, prosthetic dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dedienne Sante S.A.S.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 18 Apr 2025
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 total hip arthroplasty (THA) 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.
Detailed description
Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) 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 (mHHS) 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB-DMR-HA | – | Device: THA with SYMBOL CUP DMR HATotal 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. |
| HMB-DM-CEM | – | Device: THA with SYMBOL CUP DM CEMTotal 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. |
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 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
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 DMR HA | Device | HMB-DMR-HA |
| THA with SYMBOL CUP DM CEM | Device | HMB-DM-CEM |
Primary outcome
Implant Survival: Acetabular Cup Survival at 2-year Follow-up
Time frame: 2 years as of index operation
This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint 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 acetabular prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.
3 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gilles Estour, M.D. principal investigator
Hôpital Privé Medipole de Savoie
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 Revision Total Hip Arthroplasty and 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 18 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Acetabular Cup Survival at 2-year Follow-up (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 18 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.