Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)
SED-eval
1 other identifier
observational
200
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2021
CompletedFirst Submitted
Initial submission to the registry
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedSeptember 1, 2022
November 1, 2021
5 months
October 27, 2021
August 31, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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),
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),
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),
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) )
1 day
Study Arms (1)
Elher-Danlos syndrome patients treated with orthopedic surgery
Interventions
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) )
Eligibility Criteria
Patient over 18 years-old, suffering from Ehler-Danlos syndrome treated with surgery
You may qualify if:
- 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.
You may not qualify if:
- Patient objecting to the use of their data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (2)
Clinique Maussins-Nollet
Paris, 75019, France
Hôpital Raymond Poincaré
Garches, Île-de-France Region, 92380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2021
First Posted
November 30, 2021
Study Start
March 30, 2021
Primary Completion
September 3, 2021
Study Completion
March 30, 2022
Last Updated
September 1, 2022
Record last verified: 2021-11