UnknownNot Applicable

Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures

Denmark62 participantsStarted 2017-10-31

Plain-language summary

Intra-articular fracture is a very common fracture. The only method to treat these fractures is surgery with plate and screws followed by rehabilitation. Even though the surgeons do their best to restore the anatomy, up to 40 percent of the patients develop osteoarthritis after 10 years. Previous research has shown that immediately after fracture in the joint, the body starts an inflammatory response and activates a series of biomarkers inside the joint space. Some of these biomarkers are believed to break down the cartilage resulting in development of osteoarthritis, despite surgical treatment. Currently it is still unknown, which biomarkers are activated in the joint space, and how we can stop their deleterious action in order to prevent cartilage degradation. The purpose of this project is to identify the biomarkers in the joint space after an intra-articular ankle fracture and to evaluate how these biomarkers affect the short- and mid-terms clinical outcomes. As secondary outcomes we evaluate how fracture classification and fracture reduction affect clinical outcomes and physical activity after surgery.

Who can participate

Age range

18 Years – 65 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: * Age between 18 and 65 years * Existence of an acute fracture involving the ankle (location AO43,AO44) requiring open or closed reduction and internal or external fixation within 14 days * Being able to read and understand Danish * Informed consent Exclusion Criteria: * Open fractures * Associated arterial and nerve injuries * Multiple injured patients with an Injury Severity Score \>16 * Primary or secondary infections * Injuries associated to a Charcot foot * Signs of existing OA on X-ray * Others

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

Concentration of cytokines in fracture ankle versus non-fracture ankle

Timeframe: During surgery

Cytokines (identified in primary outcome 1) correlation with clinical outcomes (AOFAS)

Timeframe: 12 months after surgery

Trial details

NCT IDNCT03769909

SponsorUniversity of Southern Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Ankle Fractures trials