NCT05137379

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 1, 2022

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 27, 2021

Last Update Submit

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

Behavioral: A joint functional score based on the affected joint

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) )

Elher-Danlos syndrome patients treated with orthopedic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (2)

Clinique Maussins-Nollet

Paris, 75019, France

Location

Hôpital Raymond Poincaré

Garches, Île-de-France Region, 92380, France

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

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

Locations