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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46830
Enrollment
75
Registered
2017-11-02
Start date
2017-12-12
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carpal navicular fracture Scaphoid fracture

Interventions

None listed

Sponsors

Viecuri Medisch Centrum voor Noord-Limburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary outcome parameters for Phase II are the standard clinical and functional outcomes that are obtained using the PRWHE-DLV questionnaire, the pain score using VAS, the range of motion assessment and hand grip strength.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)