Phase I - Diagnostic phaseThe primary objective is to compare the clinical diagnostic performance of HR-pQCT with conventional CT imaging for diagnosis of scaphoid fractures.We hypothize that the use of the HR-pQCT in patients with a suspected…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase I * Diagnostic phase
The main outcome parameter is the proportion of patients with a diagnosed
scaphoid fracture based on either CT or HR-pQCT or CT and HR-pQCT.
Phase II * Follow-up phase
The main outcome parameters for Phase II are the changes in cortical and
trabecular bone parameters assessed by HR-pQCT and the changes in estimated
bone strength and stiffness as calculated in the µFEA.
Secondary outcome
Secondary outcome parameters for Phase II are the standard clinical and
functional outcomes that are obtained using the PRWHE-DLV questionnaire, the
pain score using VAS, the range of motion assessment and hand grip strength.
Background 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.
Study objective
Phase I - Diagnostic phase
The primary objective is to compare the clinical diagnostic performance of
HR-pQCT with conventional CT imaging for diagnosis of scaphoid fractures.
We hypothize that the use of the HR-pQCT in patients with a suspected scaphoid
fracture increases fracture detection, followed by appropriate treatment in an
earlier stage.
Phase II * Follow-up
The primary objective is to quantify the healing of diagnosed (either CT,
HR-pQCT or both) and conservatively treated scaphoid fracture using HR-pQCT
within 6 months after fracture.
The secondary objective of phase II is to investigate whether early changes in
bone strength and structure parameters can predict the 6-month functional
outcome.
Study design
In this explorative stepwise study, patients suspected of having a scaphoid
fracture will be scanned with HR-pQCT at the same time as the conventional CT
is performed in the routine workup of these patients (Phase I). Patients with a
radiographically confirmed and conservatively treated scaphoid fracture based
on CT or HR-pQCT will be asked to enroll in Phase II, with follow-up HR-pQCT
scans and questionnaires up to 6 months post-fracture.
Study burden and risks
Patients do not have any direct benefits from participation in this study . The
risks are limited.
Phase I: In addition to the X-ray and CT scan as part of the regular care, a
HR-pQCT scan will be performed. For this study, all patients with a suspected
scaphoid fracture will undergo CT scanning. For a minority of patients, this is
not according to the current clinical guideline. The radiation dose from the CT
scan is 11.5 *Sv, which is 1.7% of the individual annually background radiation
in the Netherlands. The radiation dose from this single HR-pQCT scan is 15 *Sv
(3 stacks x 5 *Sv per stack), which is 2.2% of the individual annually
background radiation in the Netherlands. The additional time to perform the
HR-pQCT scan and fill-out 2 questionnaires is 45 minutes. All patients have to
complete two questionnaires (PRWHE-DLV and VAS) .
Phase II: In addition to the regular X-rays as part of the follow-up of a
diagnosed scaphoid fracture, four additional HR-pQCT scans (at three, six,
twelve and 26 weeks after fracture) will be performed resulting in a radiation
dose of 60 *Sv. The total radiation dose of this phase is 7.4% of the
individual annually background radiation in the Netherlands. All patients have
to complete two questionnairs (PRWHE-DLV and VAS) during the four additional
visits. In addition, hand grip strength is measured three times (at six, twelve
and 26 weeks after fracture) The total study visit time for phase II per
subject will be 240 minutes, divided over 4 visits in a 6-month period. The
regular care visits will be combined with the study visits to limit the impact
of the study related activities on participants.
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
Phase 1
1. 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).
2. 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.
3. Patients who signed the Ethics Committee approved specific informed consent form prior to inclusion.;Phase 2
1. Patients who completed Phase I of the study and have a radiographically confirmed scaphoid fracture on CT or HR-pQCT.
2. Patients who signed the Ethics Committee approved specific informed consent form prior to inclusion.
3. Conservatively treated scaphoid fractures
Exclusion criteria
Phase 1
1. Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
2. Scaphoid fracture at the ipsilateral side in de medical history
3. Pregnancy.;Phase 2
1. Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
2. Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62476.068.17 |