Diagnostics and fracture healing of scaphoid fractures with High-Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)

Completed

Conditions: carpal navicular fracture
Scaphoid fracture
10005942
10017322

Registration Number: NL-OMON46830

Lead Sponsor: Viecuri Medisch Centrum voor Noord-Limburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 91

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I * Diagnostic phase<br /><br>The main outcome parameter is the proportion of patients with a diagnosed<br /><br>scaphoid fracture based on either CT or HR-pQCT or CT and HR-pQCT.<br /><br><br /><br>Phase II * Follow-up phase<br /><br>The main outcome parameters for Phase II are the changes in cortical and<br /><br>trabecular bone parameters assessed by HR-pQCT and the changes in estimated<br /><br>bone strength and stiffness as calculated in the µFEA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters for Phase II are the standard clinical and<br /><br>functional outcomes that are obtained using the PRWHE-DLV questionnaire, the<br /><br>pain score using VAS, the range of motion assessment and hand grip strength.</p><br>