Hip Arthropathy2022-09NCT06096155

Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hip Arthropathy
How many people: 46 participants
Where: 1 siteFrance
Study dates: 13 Jun 2023to 6 Jun 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 31/01/2010 and 31/12/2015.

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 01/01/2010 and 31/12/2015,
Affiliated to French health insurance system

Who cannot join

Patient who has rejected to the use of his/her personal data,
Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Hospitalier Loire Vendée Océan
Challans, Vendée, 85300

Other trials in France

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.

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.

The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.

Secondary objectives are to :

study long term patient satisfaction with their hip prosthesis,
confirm the long-term safety of these implants by studying the possible complications observed,
evaluate the performance of these implants using clinical scores.

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/Long Term Follow-up
Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision
Measured: At 7/10 years after surgery

Secondary outcomes (5)

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 7/10 years after surgery
Adverse Events
List type and occurence of adverse events
Measured: At 7/10 years after surgery
Oblivion of Prosthesis
Assess the degree of forgetfulness of the prosthesis using FJS-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 7/10 years after surgery
Absence of Squeaking
Number of patients experiencing no squeaking
Measured: At 7/10 years after surgery
Functional Improvement
The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100.
Measured: At 7/10 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 20236 Jun 2024

First posted23 Oct 2023
Study start13 Jun 2023
Primary completion6 Jun 2024
Study completion6 Jun 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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06096155
Sponsor's protocol ID: 2022-09_Sagitta EVL-R
Acronym: 2022-09
Status last verified: Apr 2025
First submitted: 17 Oct 2023
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hip Arthropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
ClinicalTrials.gov ID: NCT06096155
Acronym / sponsor ID: 2022-09 / 2022-09_Sagitta EVL-R
Conditions: Hip Arthropathy
Keywords: Total Hip Prosthesis Revision
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
Study start: 13 Jun 2023 (actual)
Primary completion: 6 Jun 2024 (actual)
Study completion: 6 Jun 2024 (actual)
First posted: 23 Oct 2023 (actual)
Results: Posted 30 Jun 2026

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.

The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.

Secondary objectives are to :

study long term patient satisfaction with their hip prosthesis,
confirm the long-term safety of these implants by studying the possible complications observed,
evaluate the performance of these implants using clinical scores.

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 31/01/2010 and 31/12/2015.

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 01/01/2010 and 31/12/2015,
Affiliated to French health insurance system

Key exclusion criteria (2 listed)

Patient who has rejected to the use of his/her personal data,
Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

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/Long Term Follow-up
Time frame: At 7/10 years after surgery
Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision

5 secondary outcomes

Patient's Satisfaction
Time frame: At 7/10 years after surgery
Adverse Events
Time frame: At 7/10 years after surgery
Oblivion of Prosthesis
Time frame: At 7/10 years after surgery
Absence of Squeaking
Time frame: At 7/10 years after surgery
Functional Improvement
Time frame: At 7/10 years after surgery

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Per Protocol Population	43	9

Primary outcome: Survival Rate at Mid/Long Term Follow-up

Time frame: At 7/10 years after surgery. Number. Unit: percentage of implant survival

Measure	Per Protocol Population n = 43
Value	95.7

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Per Protocol Population	15 of 46 (32.6%)	8 of 46 (17.4%)	23 of 43

Limitations and caveats (from the sponsor): Considering the retrospective aspect of this investigation, some preoperative data are missing or incomplete.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hip Arthropathy

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis

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 2 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 Jun 2026. 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 30 Jun 2026). 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/Long Term Follow-up (time frame: At 7/10 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06096155.

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 Jun 2026.