Arthritis, SepticSYNOVITISNCT05531227
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
An observational study of Arthritis, Septic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Septic
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to 13 Dec 2023
- 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
- Adult, Older adult
Study population: Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
Who may be able to join
- Adult patient (≥18 years old)
- having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
- clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment
- having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ
- having had treatment with local or systemic corticosteroids.
Who cannot join
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
- Absence of corticosteroid treatment
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Strasbourg, 67091
Jeannot GAUDIAS, MD, 33 3 68 76 50 64, jeannot.gaudias@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.
Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.
There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.
- Conditions
- Arthritis, Septic
- Keywords
- Arthritis, Septic, synovitis, Corticosteroid therapy, Inflammatory response, Native joint
- Medical subject headings
- Arthritis, Infectious, Synovitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete regression of the pain in a fast way
Measured: 6 months after treatment with corticosteroids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start20 Jun 2022
- Primary completion13 Dec 2023 (estimated)
- Study completion13 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, SepticStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannot GAUDIAS, MD, Principal investigator, Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531227
- Sponsor's protocol ID
- 8654
- Acronym
- SYNOVITIS
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 11 May 2023
- Results posted
- No
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
- ClinicalTrials.gov ID
- NCT05531227
- Acronym / sponsor ID
- SYNOVITIS / 8654
- Conditions
- Arthritis, Septic
- Keywords
- Arthritis, Septic, synovitis, Corticosteroid therapy, Inflammatory response, Native joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 13 Dec 2023 (estimated)
- Study completion
- 13 Dec 2023 (estimated)
- First posted
- 7 Sep 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.
Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.
Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.
There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
Key inclusion criteria (5 listed)
- Adult patient (≥18 years old)
- having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
- clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment
- having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ
- having had treatment with local or systemic corticosteroids.
Key exclusion criteria (2 listed)
- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
- Absence of corticosteroid treatment
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
Complete regression of the pain in a fast way
Time frame: 6 months after treatment with corticosteroids
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
Saïd CHAYER, PhD, HDR contact
Jeannot GAUDIAS, MD principal investigator
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
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 Arthritis, Septic, run by University Hospital, Strasbourg, France 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 5 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeannot GAUDIAS, MD (33 3 68 76 50 64, jeannot.gaudias@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete regression of the pain in a fast way (time frame: 6 months after treatment with corticosteroids). 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 11 May 2023.