- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137379
Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval) (SED-eval)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Clinique Maussins-Nollet
-
-
Île-de-France Region
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Garches, Île-de-France Region, France, 92380
- Hôpital Raymond Poincaré
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient objecting to the use of their data
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elher-Danlos syndrome patients treated with orthopedic surgery
|
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) )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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,:
|
1 day
|
|
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,:
|
1 day
|
|
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,:
|
1 day
|
|
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) ) |
1 day
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Hematologic Diseases
- Skin Diseases
- Congenital Abnormalities
- Hemostatic Disorders
- Hemorrhagic Disorders
- Skin Diseases, Genetic
- Skin Abnormalities
- Collagen Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Ehlers-Danlos Syndrome
Other Study ID Numbers
- 2020-A00808-31
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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