Diagnostics of Scaphoid Fractures With HRpQCT

NCT03899025 | Unknown

• 1 other identifier: NL62476.068.17 / V_FX_SCAPH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scaphoid Fracture; Scafoïd; Fracture

Keywords

HRpQCT; high resolution quantitative peripheral CT; Xtreme CT scan; CT scan; Diagnoses Disease; Fracture healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fracture healing using bone parameters of the HRpQCT

  untill 26weeks after fracture

• Early change in bone strength as a predictive value for long term (26weeks) functional outcome

  untill 26weeks after fracture

• Early change in trabecular structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks)

  untill 26weeks after fracture

• Early change in cortical structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks)

  untill 26weeks after fracture

Study Arms (1)

Suspected scaphoid fracture

OTHER

Patients with a suspected scaphoid fracture

Radiation: CT

Interventions

CT RADIATION

CT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist

Also known as: HRpQCT

Suspected scaphoid fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in Phase I of the study, a subject must meet all of the following criteria:
• 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).
• 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.

You may not qualify if:

• A potential subject who meets the following criterion will be excluded from participation in this study:
• Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
• Patients with a scaphoid fracture at the ipsilateral side in medical history
• Pregnancy.
• Phase II - Follow-up phase
• In order to be eligible to participate in Phase II of the study, a subject must meet all of the following criteria:
• Patients who completed Phase I of the study and have a radiographically confirmed scaphoid fracture on CT or HR-pQCT.
• Conservatively treated scaphoid fractures.
• A potential subject who meets the following criterion will be excluded from participation in this study:
• Patients, who as judged by the principal investigator, are mentally compromised or are unlikely to be compliant with the follow-up evaluations schedule.
• Pregnancy

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

VieCuri Medical Centre

Venlo, Limburg, 5912, Netherlands

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Heinrich Janzing, MD, PhD

  VieCuri MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Daniels, MD

CONTACT

0031773206880; adaniels@viecuri.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study will be composed of two subsequent phases, designed to fit within the standard clinical protocol for patients presenting at the emergency department, suspected of having a scaphoid fracture. Briefly, a patient presenting at the emergency department with a clinically suspected scaphoid fracture (by physical examination) will be subjected to standard radiographs followed by cast immobilization. When a fracture is confirmed, a conventional CT is planned within 10 days to assess fracture classification, for which the standard radiographs are insufficient. When no fracture is seen on the initial radiographs, the patient is reevaluated within 10 days after the trauma and physical examination and a conventional CT are performed. Based on the CT, a treatment strategy is decided with regular follow up visits. This clinical workup is in accordance with national and regional treatment protocols, as well as with current literature discussed in sections 1.1 and 1.2.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: April 2, 2019
• Study Start: December 12, 2017
• Primary Completion: November 28, 2019
• Study Completion: April 28, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

NL (1)