Hip Arthropathy2022-10NCT06096168
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2023to 29 Oct 2024
- 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: Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2016 and 31/12/2018.
Who may be able to join
- Patient over 18 years old at the time of surgery,
- Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018,
- Affiliated to French health insurance system
Who cannot join
- Patient who has not expressed consent for data collection and participation in the study,
- Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
- Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
- Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, 76000
About this study
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.
This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Prosthesis Revision
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate at Mid Term Follow-up
Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.
Measured: Between 4 to 7 years after surgery
Secondary outcomes (6)
Adverse Events
List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice
Measured: From per operative period to 4/6 years after surgery
Survival Rates at Mid Term Follow-up (by Component)
Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis
Measured: At 4/6 years after surgery
Survival Rates at Mid Term Follow-up (by Etiology)
Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology.
Percentage of patients with implant in place dispatched following reason for implantation
Measured: At 4/6 years after surgery
Patient's Satisfaction
Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied
Measured: At 4/6 years after surgery
Oblivion of Prosthesis
Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) :
FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Measured: At 4/6 years after surgery
Functional Improvement
Evaluate pain, walking, limping and activities of daily life using Harris Hip Score :
The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)
Measured: At 4/6 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start13 Apr 2023
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
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 Hip ArthropathyStudies 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096168
- Sponsor's protocol ID
- 2022-10_Sagitta EVL-R
- Acronym
- 2022-10
- Status last verified
- Apr 2025
- First submitted
- 17 Oct 2023
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
- ClinicalTrials.gov ID
- NCT06096168
- Acronym / sponsor ID
- 2022-10 / 2022-10_Sagitta EVL-R
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Prosthesis Revision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.
This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2016 and 31/12/2018.
Key inclusion criteria (3 listed)
- Patient over 18 years old at the time of surgery,
- Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018,
- Affiliated to French health insurance system
Key exclusion criteria (4 listed)
- Patient who has not expressed consent for data collection and participation in the study,
- Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
- Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
- Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival Rate at Mid Term Follow-up
Time frame: Between 4 to 7 years after surgery
Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.
6 secondary outcomes
Adverse Events
Time frame: From per operative period to 4/6 years after surgery
Survival Rates at Mid Term Follow-up (by Component)
Time frame: At 4/6 years after surgery
Survival Rates at Mid Term Follow-up (by Etiology)
Time frame: At 4/6 years after surgery
Patient's Satisfaction
Time frame: At 4/6 years after surgery
Oblivion of Prosthesis
Time frame: At 4/6 years after surgery
Functional Improvement
Time frame: At 4/6 years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication 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 4 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 25 Jun 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 25 Jun 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?
Survival Rate at Mid Term Follow-up (time frame: Between 4 to 7 years after surgery). 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 25 Jun 2025.