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

August 31, 2022 updated by: Ramsay Générale de Santé
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Clinique Maussins-Nollet
    • Ile De France
      • Garches, Ile De France, France, 92380
        • Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient over 18 years-old, suffering from Ehler-Danlos syndrome treated with surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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) )

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,:

  • Shoulder (SSV; QuickDash),
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,:

  • Knee (Lysholm tenger),
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,:

  • Ankle (EFAS),
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

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

September 3, 2021

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00808-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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