4DCT Wrist Reference and DRUJ

NCT05886426 | Unknown

• 1 other identifier: 114440
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Distal Radioulnar Joint Sprain

Outcome Measures

Primary Outcomes (3)

• 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 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 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 Outcomes (4)

• Volunteer study secondary outcome

  3 months

• Secondary outcome reliability study

  3 months

• Comparison with atroscopy (DRUJ instability)

  1 year

• Demographic variables

  1 year

Study Arms (3)

Reference study

Healthy participants (bilateral scans so 60 wrists) will be needed for the volunteer study to determine the visibility of the wrist joints (DRUJ, CMC-1 and MCP-1); acquire normal values and investigate the left right differences between the wrists

Diagnostic Test: 4DCT wrist and standard CT wrist

Reliability study

Healthy participants (20 wrists) that underwent a 4DCT scan for the volunteer study will be needed to undergo a second unilateral scan to investigate the intra-patient test-retest reliability of the protocol

Diagnostic Test: 4DCT wrist and standard CT wrist

DRUJ instability group

Patients with chronic unilateral wrist pain, in this study suspect for DRUJ instability, will be studied to evaluate the effect of TFCC injury on the wrist kinematics and evaluate the use of 4DCT for the diagnosis of TFCC injury

Diagnostic Test: 4DCT wrist and standard CT wrist

Interventions

4DCT wrist and standard CT wrist DIAGNOSTIC_TEST

Dynamic CT aquistion of wrist during movement and standard static wrist CT

DRUJ instability group; Reference study; Reliability study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

For the volunteer study, healthy volunteers between 18-50 years of age are included. For the clinical study, patients with unilateral chronic wrist pain suspected for DRUJ instability are included. Clinically suspect of DRUJ instability is based on the presence of a combination of the following: pain at the ulnar side of the wrist, context of wrist trauma or chronic overload; a positive piano key test and/or a positive DRUJ stress test and/or positive ballottement test. Participants with major joint stiffness or medical history of wrist surgery or fracture (radius, ulna or one of carpal bones) will not be included.

You may qualify if:

• Between 18-50 years (healthy volunteer only)
• A 3D CT scan is required.
• Informed consent from both the healthy volunteer and patient.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Officials

• Brigitte van der Heijden, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte van der Heijden, Dr.

CONTACT

+31644009575; Brigitte.vanderheijden@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 2, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05