Diagnostics of Scaphoid Fractures With HRpQCT
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|ClinicalTrials.gov Identifier: NCT03899025|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Scaphoid Fracture Scafoïd; Fracture||Radiation: CT||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
The study will be composed of two subsequent phases, designed to fit within the standard clinical protocol for patients presenting at the emergency department, suspected of having a scaphoid fracture. Briefly, a patient presenting at the emergency department with a clinically suspected scaphoid fracture (by physical examination) will be subjected to standard radiographs followed by cast immobilization. When a fracture is confirmed, a conventional CT is planned within 10 days to assess fracture classification, for which the standard radiographs are insufficient. When no fracture is seen on the initial radiographs, the patient is reevaluated within 10 days after the trauma and physical examination and a conventional CT are performed.
Based on the CT, a treatment strategy is decided with regular follow up visits. This clinical workup is in accordance with national and regional treatment protocols, as well as with current literature discussed in sections 1.1 and 1.2.
|Masking:||None (Open Label)|
|Official Title:||Diagnostics of Scaphoid Fractures With High-Resolution Peripheral Quantitative Computed Tomography - Pilot Study|
|Actual Study Start Date :||December 12, 2017|
|Estimated Primary Completion Date :||November 28, 2019|
|Estimated Study Completion Date :||April 28, 2020|
Suspected scaphoid fracture
Patients with a suspected scaphoid fracture
CT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist
Other Name: HRpQCT
- Scaphoid fracture detected on CT or HRpQCT [ Time Frame: within 10 days after presentation at the emergency department ]Scaphoid fracture detected on CT or HRpQCT, fracture on one of both scans is considered as a scaphoid fracture
- Fracture healing using bone parameters of the HRpQCT [ Time Frame: untill 26weeks after fracture ]Fracture healing using HRpQCT
- Early change in bone strength as a predictive value for long term (26weeks) functional outcome [ Time Frame: untill 26weeks after fracture ]Estimation of bone strengths by micro-finite element analysis (µFEA)
- Early change in trabecular structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks) [ Time Frame: untill 26weeks after fracture ]Bone micro-architectural parameters are measured by HR-pQCT
- Early change in cortical structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks) [ Time Frame: untill 26weeks after fracture ]Bone micro-architectural parameters are measured by HR-pQCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899025
|Contact: Anne Daniels, MDfirstname.lastname@example.org|
|VieCuri Medical Centre||Recruiting|
|Venlo, Limburg, Netherlands, 5912|
|Contact: Anne Daniels, MD 0773206880 email@example.com|
|Principal Investigator: Heinrich Janzing, MD, PhD|
|Sub-Investigator: Anne Daniels, MD|
|Principal Investigator:||Heinrich Janzing, MD, PhD||VieCuri MC|