Diagnostic performance of dynamic four-dimensional computed tomography (4D CT) compared to arthroscopy for analysing distal radioulnar joint instability

Diagnostic performance of dynamic four-dimensional computed tomography (4D CT) compared to arthroscopy for analysing distal radioulnar joint instability - 4DCT wrist reference and DRUJ

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53221

Enrollment

Registered

2023-09-05

Start date

2023-10-10

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

wrist instability

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: for the reference study (healthy volunteers): age 20-50 year, signed informed consent for diagnostic clinical study: chronic wrist pain, unilateral, suspect for TFCC lesion

Exclusion criteria

Exclusion criteria: reference study: 50 year, medical history of trauma, pain and surgery, stiff wrists, arthritis on X ray of 3D CT scan, pregnancy diagnostic clinical study: medical history of wrist fracture, know ligament lesion other dan TFCC, wrist surgery, inability to undergo an arthroscopy, wrist arthritis on X ray or 3D CT or pregnancy

Design outcomes

Primary

Measure	Time frame
The first endpoint is to define if it is possible to make low-dose, high-quality 4DCT images of the radius, ulna and carpal bones and their movements (translations and rotations related to each other) while moving the wrist and thumb according to the previously described imaging protocols, obtain normal values of the kinematic parameters and investigate the left right wrist difference. The second endpoint is to evaluate the test-retest reliability of 4DCT dynamic scanning of the radius, ulna and carpal bones). The third endpoint is the determination of the sensitivity and specificity of the 4DCT to analyse DRUJ instability in comparison with arthroscopy (gold standard).	—

Measure

Time frame

The first endpoint is to define if it is possible to make low-dose, high-quality 4DCT images of the radius, ulna and carpal bones and their movements (translations and rotations related to each other) while moving the wrist and thumb according to the previously described imaging protocols, obtain normal values of the kinematic parameters and investigate the left right wrist difference. The second endpoint is to evaluate the test-retest reliability of 4DCT dynamic scanning of the radius, ulna and carpal bones). The third endpoint is the determination of the sensitivity and specificity of the 4DCT to analyse DRUJ instability in comparison with arthroscopy (gold standard).

—

Secondary

Measure	Time frame
Clinical study: assess the association between 4DCT parameters and arthroscopic grades of TFCC injury (the Palmer classification).	—

Countries

Netherlands

Outcome results