Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis (NCT07486596) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis
Egypt40 participantsStarted 2023-12-05
Plain-language summary
The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are:
What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer complications?
Researchers will compare arthroscopic subtalar arthrodesis (ASTA) using a combined three-to-four portal approach to open in situ subtalar arthrodesis (ISTA) to see if one technique results in superior fusion rates, faster healing, and better functional outcomes.
Participants will:
Undergo one of two surgical procedures (either ASTA or ISTA) Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery Have X-rays taken to assess fusion and bone healing Complete pain and function questionnaires at each visit
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinically and radiographically confirmed symptomatic subtalar arthritis (post-traumatic, primary osteoarthritis, inflammatory or cured post-infective arthritis, symptomatic talocalcaneal coalition, or isolated subtalar arthrosis secondary to pes planovalgus deformity)
* Failure of an adequate trial of non-operative treatment for a minimum of six months
* Skeletal maturity: patients aged 18 years or older
* Ability and willingness to provide written informed consent and to comply fully with the scheduled postoperative follow-up protocol
Exclusion Criteria:
* Primary subtalar arthrodesis performed for an acute, displaced intra-articular calcaneal fracture
* Arthrodesis planned in conjunction with other simultaneous ipsilateral hindfoot procedures
* Patients with open physes (skeletal immaturity)
* Indication for a distraction-type arthrodesis requiring structural bone graft
* History of previous or current active infection at the planned operative site
* Previous failed attempt at subtalar arthrodesis
* Presence of significant peripheral vascular disease or other major medical comorbidities precluding safe surgical intervention
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.