Ankle ArthritisNCT06782269
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
An observational study of Ankle Arthritis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial summary
It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ankle Arthritis
- What is being tested?
- ankle fusion
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had an isolated ankle fusion.
Who may be able to join
- Any patient who has had an isolated ankle fusion and is over the age of 18 years old.
Who cannot join
- Participants younger than 18 years old.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that.
The aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.
Read the detailed description
Isolated ankle fusion is normally regarded as a good operation producing good pain relief and allowing patients to function well. Patients will have an early heel rise when walking and although that is often not immediately perceptible to an onlooker, it does increase the stress on the neighbouring subtalar and Chopart joints. Radiologically, subtalar joint arthrosis is common following isolated ankle fusions but not necessarily clinically symptomatic. The long term incidence of subsequent ipsilateral subtalar or Chopart joint fusions is not well known. Various different studies have shown a prevalence of osteoarthrosis (radiologically) of 24-100% in the subtalar joint and reported 84% of patients complaining of pain after 10 years. The prevalence in the Chopart joints has been reported to vary between 18-77%.
This is an observational study reviewing medical records and radiology of patients who have had an isolated ankle fusion. The data will be analysed using basic statistics with logistic regression modelling.
- Conditions
- Ankle Arthritis
- Being tested
- ankle fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle fusionProcedure or surgery
fusion of ankle joint
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of subtalar and midfoot fusions after isolated fusion of the ankle joint
To look at the incidence of subtalar and midfoot fusions after an isolated ankle fusion and what factors influenced this.
Measured: A retrospective data collection following patients from surgery to now.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782269
- Sponsor's protocol ID
- RL1901
- Status last verified
- Apr 2025
- First submitted
- 5 Sep 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
- ClinicalTrials.gov ID
- NCT06782269
- Acronym / sponsor ID
- RL1901
- Conditions
- Ankle Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jan 2025 (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.
It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that.
The aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.
Detailed description
Isolated ankle fusion is normally regarded as a good operation producing good pain relief and allowing patients to function well. Patients will have an early heel rise when walking and although that is often not immediately perceptible to an onlooker, it does increase the stress on the neighbouring subtalar and Chopart joints. Radiologically, subtalar joint arthrosis is common following isolated ankle fusions but not necessarily clinically symptomatic. The long term incidence of subsequent ipsilateral subtalar or Chopart joint fusions is not well known. Various different studies have shown a prevalence of osteoarthrosis (radiologically) of 24-100% in the subtalar joint and reported 84% of patients complaining of pain after 10 years. The prevalence in the Chopart joints has been reported to vary between 18-77%.
This is an observational study reviewing medical records and radiology of patients who have had an isolated ankle fusion. The data will be analysed using basic statistics with logistic regression modelling.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had an isolated ankle fusion.
Key inclusion criteria (1 listed)
- Any patient who has had an isolated ankle fusion and is over the age of 18 years old.
Key exclusion criteria (1 listed)
- Participants younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ankle fusionfusion of ankle joint | Procedure or surgery | – |
Primary outcome
incidence of subtalar and midfoot fusions after isolated fusion of the ankle joint
Time frame: A retrospective data collection following patients from surgery to now.
To look at the incidence of subtalar and midfoot fusions after an isolated ankle fusion and what factors influenced this.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Arthritis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS 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: opening soon, as of the sponsor's last update on 8 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (01691404418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of subtalar and midfoot fusions after isolated fusion of the ankle joint (time frame: A retrospective data collection following patients from surgery to now.). 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 8 Apr 2025.