- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06782269
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jayne Edwards
- Phone Number: 01691404143
- Email: jayne.edwards5@nhs.net
Study Contact Backup
- Name: Julie Steen
- Phone Number: 01691404418
- Email: julie.steen@nhs.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Any patient who has had an isolated ankle fusion and is over the age of 18 years old.
Exclusion Criteria:
Participants younger than 18 years old.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
A retrospective data collection following patients from surgery to now.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL1901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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