4DCT Wrist Reference and DRUJ

Distal Radioulnar Joint Sprain Clinical Trial

Official title:

Diagnostic Performance of Dynamic Four-dimensional Computed Tomography (4DCT) Compared to Arthroscopy for Analysing Distal Radioulnar Joint Instability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05886426
• Other study ID #: 114440
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Radboud University Medical Center
• Contact: Brigitte van der Heijden, Dr.
• Phone: +31644009575
• Email: Brigitte.vanderheijden[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study will consist of 3 parts. First a reference study is performed with healthy volunteers to investigate the viability of 4DCT scanning of the wrist for evaluating wrist bones configurations and movements (translations and rotations) during a new set of wrist motions that have not been evaluated in our previous study focused on the scapholunate ligament (NL72518.091.19). The following will be evaluated: the visibility of the DRUJ, the carpal metacarpal 1 (CMC-1) joint and the metacarpal phalangeal 1 (MCP-1) joint during clinically relevant wrist movements. Besides, in this study the difference is evaluated between between the left right wrist within participants during wrist motion. In future clinical practice the uninjured wrist may be used as a reference for the injured wrist, determining the left right difference in healthy volunteers will show the robustness of this technique. Subsequently a reliability study is performed to investigate the intra-patient test-retest reliability of our 4DCT scanning protocol. Lastly a diagnostic clinical study is performed on patients with chronic wrist pain, suspect for DRUJ instability. The objective of the clinical study is to determine the sensitivity and specificity of the 4DCT scan (during a series of movements in which DRUJ instability is predicted to be best visible) in the diagnosis of DRUJ instability in comparison with arthroscopic findings (gold standard). If the 4DCT shows to have a sensitivity and specificity comparable to that of wrist arthroscop

Description:

Single institution, a explorative volunteer study with participants followed by a prospective clinical study in the Radboud University Medical Center.

30 healthy participants will be included who have no medical history of wrist trauma, surgery or wrist complaints and in age range of 20-50 and; and 30 patients with chronic unilateral wrist pain suspect for DRUJ instability.

For the volunteer study all 30 healthy participants first undergo a bilateral 3D CT scan in neutral wrist position for usage of reference. The field of view of this scan includes all carpal bones and the two forearm bones. The scan technique is a Toshiba delivered application and CE certified. Subsequently, the forearms are placed in a supporting frame which minimizes lower-arm motion during 4DCT image acquisition. Prior to image acquisition, participants will undergo a training session on how to move their wrist according to the imaging protocol. A bilateral dynamic 4DCT scan is made while actively moving the wrists according to a protocoled cycle of movements. To reduce radiation exposure, the z-axis coverage is reduced to 12 cm in the 4DCT scan. Videos of the wrist movements are shown to the participant during image acquisition, which will help the participants to perform the movements at a constant pace. This will provide images with highest quality and will provide the source data considering carpal bone movements and function of ligaments during active wrist motions.

For the reliability study 20 of the participants included in the volunteer study will additively undergo an extra unilateral 4DCT scan at least 15 minutes after the bilateral 4DCT scan. Which wrist is scanned is decided by random selection. Except for the scanning being performed unilateral instead of bilateral the protocol is exactly the same as the 4DCT protocol as described above.

For this DRUJ instability study, a static 3D CT scan and a dynamic 4DCT scan of the both wrists of the patient suspect for DRUJ instability will be done after the X ray which is performed during standard clinical practice. The protocol is the same as described above in the volunteer study but the patients follow the DRUJ movement protocol with movements that are clinically relevant for DRUJ instability diagnosis.

The following radiographic signs will be evaluated: radioulnar angle; sigmoid notch to ulnar head joint distance; radioulnar ratio; radioulnar line distance; subluxation ratio; epicentre distance; radioulnar joint volume; ulnar variance and ulnar head to carpal bones joint distance [25] [26] [27] [30] [31].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Between 18-50 years (healthy volunteer only)

• A 3D CT scan is required.

• Informed consent from both the healthy volunteer and patient.

Exclusion Criteria:

A participant who meets any of the following criteria will be excluded from participation in the volunteer study:

• < 18 year and > 50 years

• medical history of wrist: trauma, pain and/or surgery

• persons with limited wrist movements

• wrists with arthritis on plain radiograph or 3D CT scan

• pregnancy

A patient with suspicion of DRUJ instability who meets any of the following criteria will be excluded from participation in the clinical study:

• medical history of wrist fracture, known ligament lesion other than the TFCC and/or wrist surgery

• inability to undergo diagnostic arthroscopy

• wrists with arthritis on plain radiograph or 3D CT scan

• pregnancy

Related Conditions & MeSH terms

• Distal Radioulnar Joint Sprain

Intervention

Diagnostic Test:
• 4DCT wrist and standard CT wrist
Dynamic CT aquistion of wrist during movement and standard static wrist CT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary study parameter Volunteer study	60 wrists of 30 healthy participants will be scanned and quantitative (e.g. in millimetres or degrees) automatic measurements of the 4DCT parameters will be performed.	3 months
Primary	Primary study parameter Reliability study	40 wrists of 20 participants will be used (of which 20 wrists have been scanned during the Volunteer study and 20 are rescanned during the reliability study) and quantitative (e.g. in millimeters or degrees) measurements of the 4DCT parameters will be performed automatically.	3 months
Primary	Primary study parameter prospective Clinical study (DRUJ instability)	4DCT parameter measurements will be compared to arthroscopically proven TFCC injuries (based on Palmar classification using unpaired student T-tests or Wilcoxon's tests, depending on the distribution. We will construct an univariate logistical regression model with as outcome a TFCC injury at arthroscopy or not, and as independent variables each one of the continuous 4DCT parameters separately, corrected for the same 4DCT parameter values of the asymptomatic contralateral wrist (and demographic parameters if proven to have a significant effect). From this, we can abstract ROC curves for different 4DCT parameters to estimate the sensitivity and specificity of these parameters.	1 year
Secondary	Volunteer study secondary outcome	Intraclass correlation coefficient (ICC) of the quantitative measurements will be calculated to assess the intra- and interobserver variability and left right similarity.	3 months
Secondary	Secondary outcome reliability study	Test-retest reliability will be calculated with the coefficient of multiple correlation evaluating the similarity between the two motion patterns. The total waveform reliability present between test and retest will be evaluated using the root mean square deviation.	3 months
Secondary	Comparison with atroscopy (DRUJ instability)	To investigate different grades of TFCC-injury on 4DCT we plan to construct a multinomial logistic regression model with the outcome variables being the different Palmer grades of TFCC injury and the independent variables the 4DCT parameters	1 year
Secondary	Demographic variables	A multivariate linear regression analysis will be performed to analyze the effect of demographic variables (age and sex) on the 4DCT parameters measured.	1 year