OsteoarthritisEPOPEENCT05527860
Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery
An observational study of Osteoarthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2022to 8 Jan 2024
- 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: Patient aged ≥18 years underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
Who may be able to join
- Patient aged ≥18 years
- Underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
- Having been followed up with the administration of at least 1 QoR-15F questionnaire postoperatively
- Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Subject who expressed their opposition to participating in the study has
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Eric NOLL, 33 3 88 12 70 76, eric.noll@chru-strasbourg.fr
Eric NOLL, MD, PhD
About this study
Official title: Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery: Retrospective Study Based on the Point of View of Patients
Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Chronic pain, Osteoarticular surgery
- Medical subject headings
- Osteoarthritis, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Score measurement of the QoR-15F questionnaire
This conditional probability will be based on the score measurement of the QoR-15F questionnaire
Measured: Score measured on D1, D3, D14 and D28 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start8 Aug 2022
- Primary completion8 Jan 2024 (estimated)
- Study completion8 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric NOLL, MD, PhD, Principal investigator, Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527860
- Sponsor's protocol ID
- 8580
- Acronym
- EPOPEE
- Status last verified
- Nov 2023
- First submitted
- 1 Sep 2022
- Last updated
- 9 Nov 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery: Retrospective Study Based on the Point of View of Patients
- ClinicalTrials.gov ID
- NCT05527860
- Acronym / sponsor ID
- EPOPEE / 8580
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Chronic pain, Osteoarticular surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 8 Jan 2024 (estimated)
- Study completion
- 8 Jan 2024 (estimated)
- First posted
- 6 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.
Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.
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
- Patient aged ≥18 years underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
Key inclusion criteria (4 listed)
- Patient aged ≥18 years
- Underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
- Having been followed up with the administration of at least 1 QoR-15F questionnaire postoperatively
- Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject who expressed their opposition to participating in the study has
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
Score measurement of the QoR-15F questionnaire
Time frame: Score measured on D1, D3, D14 and D28 postoperatively
This conditional probability will be based on the score measurement of the QoR-15F questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
Eric NOLL, MD, PhD principal investigator
Service d'Anesthésiologie - Réanimation Chirurgicale - 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 Osteoarthritis, 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 4 inclusion and 1 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 9 Nov 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 Eric NOLL, MD, PhD (33 3 88 12 70 76, eric.noll@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score measurement of the QoR-15F questionnaire (time frame: Score measured on D1, D3, D14 and D28 postoperatively). 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 9 Nov 2023.