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.
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.
- Conditions
- Ehlers Danlos Syndrome
- 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.
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)
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.
- First posted16 Oct 2026
- Study start14 Mar 2024
- Primary completion18 May 2026
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Brodbelt, Principal investigator, Walton Centre NHS Foundation Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypermobile Ehlers Danlos Syndrome Healthcare Usage and Outcomes in England
- ClinicalTrials.gov ID
- NCT07878793
- Acronym / sponsor ID
- hEDS-Out / RG499-22
- Conditions
- Ehlers Danlos Syndrome
- Keywords
- Ehlers Danlos Syndrome, EDS, Hypermobility
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand the access to services and outcomes for patients with hypermobile Ehlers Danlos Syndrome
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Patients who have a diagnosis of hEDS recorded in the GPDPR and HES, accessing services over the four year period of 2018-2021
Key exclusion criteria (1 listed)
- No EDS diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
1 secondary outcome
Determination of healthcare services accessed by hypermobile patient population
Time frame: All clinical data for patients coded with hEDS over a three year period (2019-2021)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Brodbelt principal investigator
Walton Centre NHS Foundation Trust
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.