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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | April 28, 2020 |
Est. primary completion date | November 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Phase I - Diagnostic phase Inclusion criteria In order to be eligible to participate in Phase I of the study, a subject must meet all of the following criteria: 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. Exclusion criteria A potential subject who meets the following criterion will be excluded from participation in this study: 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. Patients with a scaphoid fracture at the ipsilateral side in medical history 3. Pregnancy. Phase II - Follow-up phase Inclusion criteria In order to be eligible to participate in Phase II of the study, a subject must meet all of the following criteria: 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 A potential subject who meets the following criterion will be excluded from participation in this study: 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | VieCuri Medical Centre | Venlo | Limburg |
Lead Sponsor | Collaborator |
---|---|
VieCuri Medical Centre |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | within 10 days after presentation at the emergency department | |
Secondary | Fracture healing using bone parameters of the HRpQCT | Fracture healing using HRpQCT | untill 26weeks after fracture | |
Secondary | 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) | untill 26weeks after fracture | |
Secondary | 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 | untill 26weeks after fracture | |
Secondary | 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 | untill 26weeks after fracture |
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