Arthropathy of HipNCT05649007
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
An observational study of Arthropathy of Hip, run by Gruppo Bioimpianti S.r.l. at 1 site in France.
Trial summary
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- hip arthroplasty with prosthesis
- Type of treatment
- Medical device
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2022to 30 Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: please see inclusion/exclusion criteria
Who may be able to join
- patients>18 years
- Candidate for primary total hip replacement with femoral stem and acetabular cup
- if ostheoarthritis patients aged 18 to 85 years
- if femoral neck fracture patients aged 18 to 90 years
- patients with social security scheme
- patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation
- patients who gavee consent to partecipare in the clinical investigation
Who cannot join
- <18 years
- if female, pregnant
- patient who has already had primary hip surgery on the same side
- local or disseminated neoplastic disease
- inability to understand the study and agree to partecipate
- patients cancelling partecipation before surgery
Show all 9Show fewer
- patients under guardianship or curatorship
- patients without a social security scheme
- patients refusing to partecipate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Ducuing
Toulouse
Gerard Giordano, ortho.giordano@gmail.com
About this study
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.
Read the detailed description
The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)
- Conditions
- Arthropathy of Hip
- Being tested
- hip arthroplasty with prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroplasty with prosthesisDevice
Use of femoral stem and acetabular cup for hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
stem survival rate
Kaplan Meier survival analysis
Measured: 1 year, 3 years, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2035 (estimated)
- Study completion30 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Bioimpianti S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Giordano, medicine, Principal investigator, Hopital Ducuing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649007
- Sponsor's protocol ID
- PRCS202201
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
- ClinicalTrials.gov ID
- NCT05649007
- Acronym / sponsor ID
- PRCS202201
- Conditions
- Arthropathy of Hip
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Gruppo Bioimpianti S.r.l.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2035 (estimated)
- Study completion
- 30 Sep 2036 (estimated)
- First posted
- 13 Dec 2022 (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.
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.
Detailed description
The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- please see inclusion/exclusion criteria
Key inclusion criteria (7 listed)
- patients>18 years
- Candidate for primary total hip replacement with femoral stem and acetabular cup
- if ostheoarthritis patients aged 18 to 85 years
- if femoral neck fracture patients aged 18 to 90 years
- patients with social security scheme
Key exclusion criteria (9 listed)
- <18 years
- if female, pregnant
- patient who has already had primary hip surgery on the same side
- local or disseminated neoplastic disease
- inability to understand the study and agree to partecipate
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 |
|---|---|---|
| hip arthroplasty with prosthesisUse of femoral stem and acetabular cup for hip arthroplasty | Device | – |
Primary outcome
stem survival rate
Time frame: 1 year, 3 years, 5 and 10 years
Kaplan Meier survival analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Arthropathy of Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of 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.
Gerard Giordano, medicine principal investigator
Hopital Ducuing
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 Arthropathy of Hip, run by Gruppo Bioimpianti S.r.l. 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Dec 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessio Vitale, Biotech (+390251650371, regulatory@bioimpianti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stem survival rate (time frame: 1 year, 3 years, 5 and 10 years). 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 13 Dec 2022.