Diagnostics of Scaphoid Fractures With HRpQCT (NCT03899025) | Clinical Trial Compass
UnknownNot Applicable
Diagnostics of Scaphoid Fractures With HRpQCT
Netherlands75 participantsStarted 2017-12-12
Plain-language summary
The scaphoid bone is the most common fractured carpal bone. Scaphoid fractures represent 2-6% of all fractures and occur mainly in young, active patients aged 15 to 40. The scaphoid bone has an essential role in functionality of the wrist, acting as a pivot. Correct treatment of a scaphoid fracture depends on accurate and timely diagnosis, and inadequate treatment can result in avascular necrosis (up to 40%), nonunion (5-21%) and early osteoarthritis (up to 32%) that may seriously impair wrist function. In addition, impaired consolidation of scaphoid fractures results in longer immobilization leading to significant functional and psychosocial impairment thus having considerable socio-economic consequences and negative impact on the quality of life.
Current diagnostic pathways can take up to two weeks to diagnose (or exclude) a scaphoid fracture, leading to overtreatment in patients with a suspected scaphoid fracture since only 15 to 30% of suspected scaphoid fractures in the Netherlands annually is found to be an actual fracture.
Thus, there is significant room for improvement in the diagnostic pathway of scaphoid fractures.
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
. Adults (18 years or older) who visit the emergency department of the VieCuri Medical Center Venlo with a clinically suspected scaphoid fracture due to a trauma (\<1 week after trauma).
. Patients who understand the conditions of the study and are willing and able to comply with the scheduled radiographic evaluations and the prescribed treatment and rehabilitation.
. Patients who signed the Ethics Committee approved specific informed consent form prior to inclusion.
Exclusion criteria
. Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
. Patients with a scaphoid fracture at the ipsilateral side in medical history
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
1
Scaphoid fracture detected on CT or HRpQCT
Timeframe: within 10 days after presentation at the emergency department
. Patients who completed Phase I of the study and have a radiographically confirmed scaphoid fracture on CT or HR-pQCT.
. Patients who signed the Ethics Committee approved specific informed consent form prior to inclusion.
. Conservatively treated scaphoid fractures.
. Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.