Scaphoid Fracture Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05362240 -
Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in SNAC Wrist
|
N/A | |
| Terminated |
NCT02605096 -
Pilot Study to Test the Feasibility of the Use of MRI in Suspected Scaphoid Fractures
|
Phase 3 | |
| Not yet recruiting |
NCT05358015 -
Vascularized Bone Grafts for Treatment of Scaphoid Nonunion
|
N/A | |
| Completed |
NCT04892862 -
Dorsal and Volar Surgeries Preferred in Scaphoid Pseudorthrosis Comparison of Effects on Kinematics
|
N/A | |
| Recruiting |
NCT02801149 -
The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography
|
N/A | |
| Recruiting |
NCT05574582 -
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
|
N/A | |
| Completed |
NCT00205985 -
Operative Versus Conservative Treatment of Scaphoid Fractures
|
Phase 4 | |
| Recruiting |
NCT03856450 -
Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
|
N/A | |
| Recruiting |
NCT05183477 -
Fast Track for Wrist and Scaphoid Fractures
|
N/A | |
| Completed |
NCT05075135 -
Acceptability and Safety of 3D Printed Wrist-based Splints
|
N/A | |
| Recruiting |
NCT05835440 -
Improving Wrist Injury Pathways (I-WIP) Study
|
||
| Completed |
NCT04776551 -
Percutaneous Fixation of Acute Scaphoid Fractures
|
N/A |