CompletedNot Applicable

The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

United States39 participantsStarted 2015-01-28

Plain-language summary

The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Who can participate

Age range

18 Years – 95 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: * Over the age of 18 * Ankle and Subtalar arthritis * Failed non-operative management Exclusion Criteria: * Patients who do not meet the minimum age of 18 years.

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.

What they're measuring

Change in Pain Assessment

Timeframe: Pre-operative up to 2 years post surgery

Change in Functional Assessment

Timeframe: Pre-operative up to 2 years post surgery

Change in Functional Assessment

Timeframe: Pre-operative up to 2 years post surgery

Fusion, as measured by radiograph and CT scan

Timeframe: Pre-operative up to 2 years post surgery

Trial details

NCT IDNCT02324907

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-09

View on ClinicalTrials.gov More Ankle Arthritis trials

Who can participate

Age range

18 Years – 95 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: * Over the age of 18 * Ankle and Subtalar arthritis * Failed non-operative management Exclusion Criteria: * Patients who do not meet the minimum age of 18 years.

What they're measuring

Change in Pain Assessment

Timeframe: Pre-operative up to 2 years post surgery

Change in Functional Assessment

Timeframe: Pre-operative up to 2 years post surgery

Change in Functional Assessment

Timeframe: Pre-operative up to 2 years post surgery

Fusion, as measured by radiograph and CT scan

Timeframe: Pre-operative up to 2 years post surgery