4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries

Scapholunate Interosseous Ligament Injury Clinical Trial

— 4DCT  

Official title:

4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193996
• Other study ID #: 17-001279
• Secondary ID: 1R01AR071338-01
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: January 23, 2023

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study seeks to determine whether the 4DCT imaging technique can be used to replace current invasive diagnostic tests for ligament injuries of the wrist.

Description:

Aim 1:

40 cadaveric forearm/hand specimens will be obtained from the Mayo Clinic Anatomical Bequest program. 10 will be used to refine the ligament injury model and 30 will be used as follows. The specimens will undergo radiographic screening and will be excluded from the study if they have evidence of fracture, bony trauma, significant arthritic changes, or previous surgeries. The tendons will be loaded. The remaining soft tissues will be dissected from the proximal ulna and radius. Polymethylmethacrylate (PMMA) resin will be used to affix the proximal radius and ulna in a circular acrylic fixture. The custom wrist motion simulator was designed to generate muscle-assisted flexion-extension and radial-ulnar deviation movements and is CT-compatible. Each tendon will be dynamically loaded with a constant 10 N, maintained throughout the movement in the following conditions: wrist flexion-extension and radial-ulnar deviation. The hand will be fixed in a grip that is connected to a programmable linear actuator. The linear actuator drives the grip back-and-forth along the x-axis with free-motion along the z-axis. The linear actuator will be programmed to allow the wrist to perform a full radial-ulnar or flexion-extension motion at 30 deg/sec which simulates in vivo wrist motion speeds. A motion cycle is approximately 2 seconds. The wrist will be cycled 100 times in flexion-extension prior to each testing condition. A static CT image will be acquired in the neutral posture. Then, each wrist will be imaged using 4DCT during flexion-extension and radial-ulnar deviation, in the following conditions: intact (control), volar SLIL cut, membranous SLIL cut, dorsal SLIL cut, radioscaphocapitate ligament cut, and long radiolunate ligament cut.

Aim 2:

4DCT scanning will be performed bilaterally on 60 patients (30 males, 30 females) with unilateral SLIL injury who are scheduled to undergo a surgical intervention. In addition, patients will have pre-surgical volar and dorsal arthroscopic confirmation of ligament injury, categorized by Geissler and European Wrist Arthroscopy Society (EWAS) classifications; video recording of the arthroscopy will be obtained for later analysis. PRWE and VAS questionnaires will be completed at the 4DCT visit for the injured wrist and the Total Patient Rated Wrist Evaluation (PRWE) score (sum of pain and function subscales) and composite change in Visual Analog Pain Scale (VAS) score used in the analysis. 4DCT wrist data will be obtained while the subjects perform flexion-extension and radial-ulnar deviation. The dynamic image sequence will be processed with existing software tools to obtain metrics describing the interosseous distances between the articular surfaces of the scaphoid, lunate, and radius, during the movement cycles. Given the difficulty of diagnosing SLIL injury, the uninjured contralateral wrist is often used as a "control" for comparison by physicians; therefore, the difference in right/left metrics will be used in the study.

Aim 3:

The same 60 patients ( see Aim 2) will be evaluated. Surgeons will assess pre-surgical scapholunate interosseus distances (quantified using 4DCT in Aim 2) and document a treatment plan to address the particular injury. Subsequently, 4DCT-based treatment plans will be compared with arthroscopic evaluation (obtained in Aim 2); any existing wrist x-rays (e.g. AP, lateral, stress views) and MRIs may be used in this comparison as well. The surgeon will then select and perform the targeted surgical intervention based on both 4DCT and arthroscopic findings. 4DCT will be performed, and the PRWE and VAS completed by patients at 1 year postoperatively; quantification of radioscaphoid contact patterns will be assessed during bilateral wrist flexion-extension and radial-ulnar deviation to determine if normal patterns of motion are restored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. unilateral scapholunate instability

2. point tenderness over the dorsal aspect of the scapholunate joint

3. positive Watson shift sign (Watson et al., J Hand Surg Am, 1988; 13:657-60);

4. suspected pathology on previous fluoroscopy or MRI;

Exclusion Criteria:

1. previously-diagnosed rheumatological conditions or connective tissue diseases

2. inability to be appropriately positioned in the scanner for the imaging

3. congenital malformations of the wrist or forearm

4. diagnosed wrist osteoarthritis

5. age under 18 or over 60

Related Conditions & MeSH terms

• Scapholunate Interosseous Ligament Injury
• Wounds and Injuries

Intervention

Device:
• 4DCT
4DCT will be used to assess the location of the torn scapholunate interosseus ligament.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Kristin Zhao, PhD	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.	Baseline, Post-4DCT Viewing, Post-Arthroscopy estimates or observations were made by the attending surgeon of Geissler grading, an arthroscopic classification of carpal instability and suggested management of acute injuries to the SLIL. Lower Geissler grading indicates milder damage and suggests more conservative injury management, and higher Geissler grading indicates more severe damage and suggests more aggressive injury management.	Baseline, Post-4DCT Viewing, Post-Arthroscopy
Secondary	Subject Perception of Surgical Outcome	Baseline and one year post-surgery Patient-Rated Wrist Evaluation (PRWE) Score will measure patient perception of change. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, with higher numbers representing more pain and disability, and consists of 2 subscales as well as a total score: Pain subscale: contains 5 items each of which is further rated from 0-10. The maximum score in this section is 50 and minimum 0, with a higher score suggesting more severe and frequent pain.; Function subscale: contains total 10 items. The maximum score in this section is 50 and minimum 0, with a higher score suggesting greater difficulty performing activities of daily living.; Total score: all subscales together. The maximum score in this section is 100 and minimum 0, with a higher score suggesting more pain and disability overall.	Baseline and 1 Year Post-Surgery

External Links

•   Mayo Clinical Trials