Scaphoid FractureNCT03899025
Diagnostics of Scaphoid Fractures With HRpQCT
A study testing CT in people with Scaphoid Fracture and Scafoïd; Fracture, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scaphoid Fracture, Scafoïd; Fracture
- What is being tested?
- CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Dec 2017to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in Phase I of the study, a subject must meet all of the following 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.
- In order to be eligible to participate in Phase II of the study, a subject must meet all of the following criteria:
- 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.
Who cannot join
- A potential subject who meets the following criterion will be excluded from participation in this study:
- 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
- Pregnancy.
- Phase II - Follow-up phase
- A potential subject who meets the following criterion will be excluded from participation in this study:
- Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostics of Scaphoid Fractures With High-Resolution Peripheral Quantitative Computed Tomography - Pilot Study
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.
Read the detailed description
Scaphoid fractures
The scaphoid bone is the most frequently occurring fracture of the carpal bones. Scaphoid fractures represent 2-6% of all fractures and 90% of all carpal fractures in the Netherlands. Scaphoid fractures typically occur in young, active patients aged 15 to 40 years old. The exact incidence is unknown, but approximately 21,000 scaphoid fractures are suspected in the Netherlands each year. However, only 15 to 30% represent real fractures. Because a significant amount of fractures (up to 65% immediately after injury) remain radiographically occult with conventional radiographic imaging, there is a trend of overtreatment of suspected scaphoid fractures, which means a lot of wrists are immobilized unnecessary.
A scaphoid fracture has potentially far reaching consequences for the patient, considering the unique nature of this bone in the human body, as it articulates with five surrounding bones in the wrist. Because of this, it has an essential role in functionality of the wrist, acting as a pivot. The treatment of scaphoid fractures is found to be a challenge. Failure can result in avascular necrosis (up to 40%), nonunion (up to 21%) of the fracture and subsequently early osteoarthritis (up to 32%). Displaced fractures of the scaphoid bone can lead to an even higher rate of complications.
The results of surgical treatment are variable13 and surgery is often initiated in a late phase of the treatment. Both complicated fracture healing and surgical treatment in a late phase of the treatment have severe socio-economical consequences.
Diagnosis and follow up of scaphoid fractures
The accurate diagnosis of a scaphoid fracture is the first step of successful treatment of this injury. Delay in treatment has been shown to negatively affect outcome, with adequate treatment of a scaphoid fracture increasing union rates from 55% to 90-100%.
However, this knowledge supports the overtreatment-tendency in patients suspected of having a scaphoid fracture at the emergency department. It is estimated that only 15-30% of these patients actually have a scaphoid fracture, 1,3-5 resulting in a substantial number of patients wearing a cast for a limited period of time when they do not need it.
As studies have shown, the clinical evaluation directly after trauma is not capable of reliably proving or excluding a scaphoid fracture. Current clinical practice in the Netherlands consists of conventional X-ray, followed by CT one week later when the initial radiographs are negative, but repeated clinical examination does not exclude scaphoid injury. Other imaging modalities such as MRI or bone scintigraphy are also being used. CT scan gives more useful information about the anatomy of a possible fracture and is more easily available in the Dutch situation than MRI and bone scintigraphy. Aside from the diagnostic delay it is difficult to objectify fracture healing with x-ray, CT scan, MRI or bone scintigraphy. Therefore, there is room for improvement of the arsenal to accurately and timely diagnose and classify scaphoid fractures and to evaluate scaphoid fracture healing.
High resolution peripheral quantitative computed tomography
The current clinical imaging techniques used in the diagnosis of scaphoid fractures as described above lack the resolving power needed for detailed cortical measurements and visualization of the trabecular morphology, for which a spatial resolution lower than 200 µm is needed. The development of high resolution CT scanners with a spatial resolution of 150 to 95 µm enables these measurements, specifically for the extremities. These so-called high-resolution peripheral quantitative CT (HR-pQCT) scanners are smaller and less expensive than current clinical whole body CT scanners. A specific HR-pQCT scanner to visualize and assess trabecular structure of peripheral bones in a clinical (trial) setting is the XtremeCT platform (Scanco Medical AG, Switserland). The most recent iteration of this scanner, the XtremeCT-2, has a voxel size of 61 µm and a spatial resolution of 95 µm, which enables the direct assessment of bone micro-architectural parameters. In addition, after digitalization of the trabecular structure a so called virtual bone biopsy is available, which enables the estimation of bone strength parameters by micro-finite element analysis (µFEA).
Validation and reproducibility studies of both the HR-pQCT scanner as well as µFEA have been performed, and in the last decade widespread experience has been gathered concerning the use of these techniques in (clinical) research.
- Conditions
- Scaphoid Fracture, Scafoïd; Fracture
- Being tested
- CT
- Keywords
- HRpQCT, high resolution quantitative peripheral CT, Xtreme CT scan, CT scan, Diagnoses Disease, Fracture healing
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTRadiation
Also called HRpQCT
CT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist
| Study group | Role | What they receive |
|---|---|---|
| Suspected scaphoid fracture | Other | Patients with a suspected scaphoid fracture Receives: Radiation: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scaphoid fracture detected on CT or HRpQCT
Scaphoid fracture detected on CT or HRpQCT, fracture on one of both scans is considered as a scaphoid fracture
Measured: within 10 days after presentation at the emergency department
Secondary outcomes (4)
Fracture healing using bone parameters of the HRpQCT
Fracture healing using HRpQCT
Measured: untill 26weeks after fracture
Early change in bone strength as a predictive value for long term (26weeks) functional outcome
Estimation of bone strengths by micro-finite element analysis (µFEA)
Measured: untill 26weeks after fracture
Early change in trabecular structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks)
Bone micro-architectural parameters are measured by HR-pQCT
Measured: untill 26weeks after fracture
Early change in cortical structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks)
Bone micro-architectural parameters are measured by HR-pQCT
Measured: untill 26weeks after fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start12 Dec 2017
- Primary completion28 Nov 2019
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heinrich Janzing, MD, PhD, Principal investigator, VieCuri MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899025
- Sponsor's protocol ID
- NL62476.068.17 / V_FX_SCAPH
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2017
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics of Scaphoid Fractures With High-Resolution Peripheral Quantitative Computed Tomography - Pilot Study
- ClinicalTrials.gov ID
- NCT03899025
- Acronym / sponsor ID
- NL62476.068.17 / V_FX_SCAPH
- Conditions
- Scaphoid Fracture, Scafoïd; Fracture
- Keywords
- HRpQCT, high resolution quantitative peripheral CT, Xtreme CT scan, CT scan, Diagnoses Disease, Fracture healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scaphoid fractures
The scaphoid bone is the most frequently occurring fracture of the carpal bones. Scaphoid fractures represent 2-6% of all fractures and 90% of all carpal fractures in the Netherlands. Scaphoid fractures typically occur in young, active patients aged 15 to 40 years old. The exact incidence is unknown, but approximately 21,000 scaphoid fractures are suspected in the Netherlands each year. However, only 15 to 30% represent real fractures. Because a significant amount of fractures (up to 65% immediately after injury) remain radiographically occult with conventional radiographic imaging, there is a trend of overtreatment of suspected scaphoid fractures, which means a lot of wrists are immobilized unnecessary.
A scaphoid fracture has potentially far reaching consequences for the patient, considering the unique nature of this bone in the human body, as it articulates with five surrounding bones in the wrist. Because of this, it has an essential role in functionality of the wrist, acting as a pivot. The treatment of scaphoid fractures is found to be a challenge. Failure can result in avascular necrosis (up to 40%), nonunion (up to 21%) of the fracture and subsequently early osteoarthritis (up to 32%). Displaced fractures of the scaphoid bone can lead to an even higher rate of complications.
The results of surgical treatment are variable13 and surgery is often initiated in a late phase of the treatment. Both complicated fracture healing and surgical treatment in a late phase of the treatment have severe socio-economical consequences.
Diagnosis and follow up of scaphoid fractures
The accurate diagnosis of a scaphoid fracture is the first step of successful treatment of this injury. Delay in treatment has been shown to negatively affect outcome, with adequate treatment of a scaphoid fracture increasing union rates from 55% to 90-100%.
However, this knowledge supports the overtreatment-tendency in patients suspected of having a scaphoid fracture at the emergency department. It is estimated that only 15-30% of these patients actually have a scaphoid fracture, 1,3-5 resulting in a substantial number of patients wearing a cast for a limited period of time when they do not need it.
As studies have shown, the clinical evaluation directly after trauma is not capable of reliably proving or excluding a scaphoid fracture. Current clinical practice in the Netherlands consists of conventional X-ray, followed by CT one week later when the initial radiographs are negative, but repeated clinical examination does not exclude scaphoid injury. Other imaging modalities such as MRI or bone scintigraphy are also being used. CT scan gives more useful information about the anatomy of a possible fracture and is more easily available in the Dutch situation than MRI and bone scintigraphy. Aside from the diagnostic delay it is difficult to objectify fracture healing with x-ray, CT scan, MRI or bone scintigraphy. Therefore, there is room for improvement of the arsenal to accurately and timely diagnose and classify scaphoid fractures and to evaluate scaphoid fracture healing.
High resolution peripheral quantitative computed tomography
The current clinical imaging techniques used in the diagnosis of scaphoid fractures as described above lack the resolving power needed for detailed cortical measurements and visualization of the trabecular morphology, for which a spatial resolution lower than 200 µm is needed. The development of high resolution CT scanners with a spatial resolution of 150 to 95 µm enables these measurements, specifically for the extremities. These so-called high-resolution peripheral quantitative CT (HR-pQCT) scanners are smaller and less expensive than current clinical whole body CT scanners. A specific HR-pQCT scanner to visualize and assess trabecular structure of peripheral bones in a clinical (trial) setting is the XtremeCT platform (Scanco Medical AG, Switserland). The most recent iteration of this scanner, the XtremeCT-2, has a voxel size of 61 µm and a spatial resolution of 95 µm, which enables the direct assessment of bone micro-architectural parameters. In addition, after digitalization of the trabecular structure a so called virtual bone biopsy is available, which enables the estimation of bone strength parameters by micro-finite element analysis (µFEA).
Validation and reproducibility studies of both the HR-pQCT scanner as well as µFEA have been performed, and in the last decade widespread experience has been gathered concerning the use of these techniques in (clinical) research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suspected scaphoid fracture | Other | Radiation: CTPatients with a suspected scaphoid fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in Phase I of the study, a subject must meet all of the following 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.
- In order to be eligible to participate in Phase II of the study, a subject must meet all of the following criteria:
Key exclusion criteria (8 listed)
- A potential subject who meets the following criterion will be excluded from participation in this study:
- 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
- Pregnancy.
- Phase II - Follow-up phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTAlso: HRpQCTCT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist | Radiation | Suspected scaphoid fracture |
Primary outcome
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
4 secondary outcomes
Fracture healing using bone parameters of the HRpQCT
Time frame: untill 26weeks after fracture
Early change in bone strength as a predictive value for long term (26weeks) functional outcome
Time frame: untill 26weeks after fracture
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich Janzing, MD, PhD principal investigator
VieCuri MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT in people with Scaphoid Fracture and Scafoïd; Fracture, run by VieCuri Medical Centre at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scaphoid fracture detected on CT or HRpQCT (time frame: within 10 days after presentation at the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.