Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)

Ehlers-Danlos Syndrome Clinical Trial

— SED-eval  

Official title:

Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137379
• Other study ID #: 2020-A00808-31
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2022
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Behavioral:
• A joint functional score based on the affected joint
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) )

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches	Ile De France
France	Clinique Maussins-Nollet	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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