Ehlers-Danlos SyndromeSED-evalNCT05137379
Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)
An observational study of Ehlers-Danlos Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- A joint functional score based on the affected joint
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Mar 2021to 30 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 18 years-old, suffering from Ehler-Danlos syndrome treated with surgery
Who may be able to join
- Patient over 18 years-old suffering from Ehlers-Danlos Syndrome and belonging to the EDS cohort of Raymond Poincaré Hospital in Garches
- Patient with joint involvement of the shoulder treated by surgery
- Patient with ankle joint damage treated by surgery
- Patient with joint damage to the knee treated by surgery
- Patient with elbow joint damage treated by surgery
- Patient with joint involvement of the wrist treated by surgery
- Patient affiliated or beneficiary of a social security scheme
- Patient who has been informed of the research and does not object to the use of his data.
Who cannot join
- Patient objecting to the use of their data
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Raymond Poincaré
Garches, Île-de-France Region, 92380
Clinique Maussins-Nollet
Paris, 75019
About this study
The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery.
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- A joint functional score based on the affected joint
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A joint functional score based on the affected jointBehavioural
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: Shoulder (SSV; QuickDash), Knee (Lysholm tenger), Ankle (EFAS), Elbow and wrist (QuickDash) )
| Study group | Role | What they receive |
|---|---|---|
| Elher-Danlos syndrome patients treated with orthopedic surgery | Not described Receives: Behavioral: A joint functional score based on the affected joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint function score according to the affected joint
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,:
- Shoulder (SSV; QuickDash),
Measured: 1 day
Joint function score according to the affected joint
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,:
- Knee (Lysholm tenger),
Measured: 1 day
Joint function score according to the affected joint
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,:
- Ankle (EFAS),
Measured: 1 day
Joint function score according to the affected joint
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,:
-Elbow and wrist (QuickDash) )
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start30 Mar 2021
- Primary completion3 Sep 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137379
- Sponsor's protocol ID
- 2020-A00808-31
- Acronym
- SED-eval
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)
- ClinicalTrials.gov ID
- NCT05137379
- Acronym / sponsor ID
- SED-eval / 2020-A00808-31
- Conditions
- Ehlers-Danlos Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 30 Nov 2021 (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.
The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elher-Danlos syndrome patients treated with orthopedic surgery | – | Behavioral: A joint functional score based on the affected joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years-old, suffering from Ehler-Danlos syndrome treated with surgery
Key inclusion criteria (8 listed)
- Patient over 18 years-old suffering from Ehlers-Danlos Syndrome and belonging to the EDS cohort of Raymond Poincaré Hospital in Garches
- Patient with joint involvement of the shoulder treated by surgery
- Patient with ankle joint damage treated by surgery
- Patient with joint damage to the knee treated by surgery
- Patient with elbow joint damage treated by surgery
Key exclusion criteria (1 listed)
- Patient objecting to the use of their data
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 |
|---|---|---|
| A joint functional score based on the affected jointA joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: Shoulder (SSV; QuickDash), Knee (Lysholm tenger), Ankle (EFAS), Elbow and wrist (QuickDash) ) | Behavioural | Elher-Danlos syndrome patients treated with orthopedic surgery |
Primary outcome
Joint function score according to the affected joint
Time frame: 1 day
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: * Shoulder (SSV; QuickDash),
Joint function score according to the affected joint
Time frame: 1 day
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: * Knee (Lysholm tenger),
Joint function score according to the affected joint
Time frame: 1 day
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: * Ankle (EFAS),
Joint function score according to the affected joint
Time frame: 1 day
A joint function score according to the affected joint in patients with Ehlers-Danlos syndrome treated by surgery,: -Elbow and wrist (QuickDash) )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers-Danlos Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites 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 8 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: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Joint function score according to the affected joint (time frame: 1 day). The study lists 4 primary outcomes in all. 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 16 Jul 2026.