Diagnostics of Scaphoid Fractures With HRpQCT

About this trial

Last updated 7 years ago

Study ID

NL62476.068.17 / V_FX_SCAPH

Status

Unknown

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the Participation Requirements?

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