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Diagnostics of Scaphoid Fractures With HRpQCT

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ClinicalTrials.gov Identifier: NCT03899025
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Heinrich Janzing, VieCuri Medical Centre

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.


Condition or disease Intervention/treatment Phase
Scaphoid Fracture Scafoïd; Fracture Radiation: CT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostics of Scaphoid Fractures With High-Resolution Peripheral Quantitative Computed Tomography - Pilot Study
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Suspected scaphoid fracture
Patients with a suspected scaphoid fracture
Radiation: CT
CT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist
Other Name: HRpQCT




Primary Outcome Measures :
  1. Scaphoid fracture detected on CT or HRpQCT [ Time Frame: within 10 days after presentation at the emergency department ]
    Scaphoid fracture detected on CT or HRpQCT, fracture on one of both scans is considered as a scaphoid fracture


Secondary Outcome Measures :
  1. Fracture healing using bone parameters of the HRpQCT [ Time Frame: untill 26weeks after fracture ]
    Fracture healing using HRpQCT

  2. Early change in bone strength as a predictive value for long term (26weeks) functional outcome [ Time Frame: untill 26weeks after fracture ]
    Estimation of bone strengths by micro-finite element analysis (µFEA)

  3. Early change in trabecular structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks) [ Time Frame: untill 26weeks after fracture ]
    Bone micro-architectural parameters are measured by HR-pQCT

  4. Early change in cortical structure parameters measured by HRpQCT as a predictive value for long term functional outcome (26weeks) [ Time Frame: untill 26weeks after fracture ]
    Bone micro-architectural parameters are measured by HR-pQCT



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899025


Contacts
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Contact: Anne Daniels, MD 0031773206880 adaniels@viecuri.nl

Locations
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Netherlands
VieCuri Medical Centre Recruiting
Venlo, Limburg, Netherlands, 5912
Contact: Anne Daniels, MD    0773206880    adaniels@viecuri.nl   
Principal Investigator: Heinrich Janzing, MD, PhD         
Sub-Investigator: Anne Daniels, MD         
Sponsors and Collaborators
VieCuri Medical Centre
Investigators
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Principal Investigator: Heinrich Janzing, MD, PhD VieCuri MC

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Responsible Party: Dr. Heinrich Janzing, Principal investigator, VieCuri Medical Centre
ClinicalTrials.gov Identifier: NCT03899025     History of Changes
Other Study ID Numbers: NL62476.068.17 / V_FX_SCAPH
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Heinrich Janzing, VieCuri Medical Centre:
HRpQCT
high resolution quantitative peripheral CT
Xtreme CT scan
CT scan
Diagnoses Disease
Fracture healing

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries