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Ehlers Danlos SyndromehEDS-OutNCT07878793

Hypermobile Ehlers Danlos Syndrome Healthcare Usage and Outcomes in England

An observational study of Ehlers Danlos Syndrome, run by Walton Centre NHS Foundation Trust.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To understand the access to services and outcomes for patients with hypermobile Ehlers Danlos Syndrome Read more about this study

Who is it for?
Any age
Conditions the study is for
Ehlers Danlos Syndrome
How many people
0 participants
Where
No sites listed yet
Study dates
14 Mar 2024to 18 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who have a diagnosis of hEDS recorded in the GPDPR and HES, accessing services over the four year period of 2018-2021

Who may be able to join

  • Patients who have a diagnosis of hEDS recorded in the GPDPR and HES, accessing services over the four year period of 2018-2021

Who cannot join

  • No EDS diagnosis

About this study

To understand the access to services and outcomes for patients with hypermobile Ehlers Danlos Syndrome

Read the detailed description

Ehlers Danlos (EDS) describes a range of connective tissue disorders characterised by joint hypermobility and hyperextensible skin. Thirteen of the fourteen sub-types have been attributed to molecular causes associated with alterations in 20 genes, most of which encode fibrillar collagen proteins (types I, III and V). Hypermobile EDS or hEDS is the most common EDS sub-type and the only sub-type to have a currently unknown genetic basis. Diagnosis is made with a clinical graded criteria scale, the presence of complications and family history.

Complications of hEDS affect multiple body systems. Neurological complications include cerebrospinal fluid leak when associated with Chiari malformation Type I, and spinal hypermobility (associated with ligament laxity) which has been described as atlanto-axial instability (AAI) or cranio-cervical instability (CCI). hEDS patients undergo cervical stabilisation surgery for spinal hypermobility in other countries, the role of this procedure has been questioned. The clinical and radiological biomarkers of spinal instability are suggested in the literature but are highly controversial and generally not accepted by the UK neurosurgical community. Fixation for cervical spine injuries, rheumatoid arthritis, gross infection, and discogenic disease, where patients also have EDS, is not in contention. What is debated is the role of fixation for hEDS patients for excess mobility of their cervical spine alone, without other pathological features.

Many patients are in fact going abroad for surgical spinal stabilisation and a recent survey of these patients suggested significant benefit from fixation, albeit with a high complication and multiple surgery rate. The recognised treatment for spinal instability would ideally include an integrated pathway of rehabilitation and pain management, (perhaps under the care of rheumatology services) before considering any form of surgery. Currently, there appears to be no coordinated system of care for these patients in the UK nor for UK hEDS patients travelling abroad for surgery. Local rheumatologists state there are nationally commissioned services, whilst the national providers state that they are a diagnostic service for all types of EDS other than the hypermobile type and subsequent treatment should be provided locally. Some pain management services do treat EDS patients, but availability varies by region.

Ultimately, there is very little published data available to demonstrate the services available, the size of this group of patients or their service usage and need. The adequacy of the data available in national databases is also not yet clear.

Given the significant obscurity regarding the clinical prevalence and needs of this patient subgroup as well as the recognised phenomenon of patients travelling abroad for their treatments, it is necessary to investigate these patients and understand their condition further in the UK. This includes detailing the use of resources to better understand the available facilities for this patient group and to help understand the reasons for travel.

Keywords
Ehlers Danlos Syndrome, EDS, Hypermobility
Medical subject headings
Ehlers-Danlos Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of size and demographic of hypermobile population in England

    Development of overall patient totals, along with the completion of trend analysis results in regards to demographics, regarding all UK patients coded with hEDS (Approximately 5,500 patients).

    Raw data being reviewed in order to generate the overall totals and trend analysis include; GP attendance, secondary care attendance, hospital stay, procedures, complication rates, COVID-19 infection rates, and association of above factors with COVID-19 Infection.

    Measured: All clinical data for patients coded with hEDS over a three year period (2019-2021)

Secondary outcomes (1)
  1. Determination of healthcare services accessed by hypermobile patient population

    Overall results regarding healthcare services accessed by all UK patients coded with hEDS (Approximately 5,500 patients).

    The raw data collected and processed to determine this result will be clinical outcomes including; GP attendance, secondary care attendance, hospital stay, procedures, complication rates, COVID-19 infection rates, and association of above factors with COVID-19 Infection.

    Measured: All clinical data for patients coded with hEDS over a three year period (2019-2021)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start14 Mar 2024
  3. Primary completion18 May 2026
  4. Study completion18 May 2026

Why it stopped: Data application was made to NHS England but difficulties encountered in obtaining relevant data, and how this data could be accessed and processed. CI/PI has now since retired from the trust before data could be obtained.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878793
Sponsor's protocol ID
RG499-22
Acronym
hEDS-Out
Status last verified
Oct 2026
First submitted
2 Sep 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ehlers Danlos Syndrome, run by Walton Centre NHS Foundation Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of size and demographic of hypermobile population in England (time frame: All clinical data for patients coded with hEDS over a three year period (2019-2021)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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