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Scapholunate Interosseous Ligament Injury4DCTNCT03193996

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

A study testing 4DCT in people with Scapholunate Interosseous Ligament Injury, run by Kristin Zhao, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
4DCT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
23 Oct 2017to 23 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • unilateral scapholunate instability
  • point tenderness over the dorsal aspect of the scapholunate joint
  • positive Watson shift sign (Watson et al., J Hand Surg Am, 1988; 13:657-60);
  • suspected pathology on previous fluoroscopy or MRI;

Who cannot join

  • previously-diagnosed rheumatological conditions or connective tissue diseases
  • inability to be appropriately positioned in the scanner for the imaging
  • congenital malformations of the wrist or forearm
  • diagnosed wrist osteoarthritis
  • age under 18 or over 60

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
4DCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4DCTDevice

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

Study groups in NCT03193996
Study groupRoleWhat they receive
SLIL InjuryOtherSurgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
Receives: Device: 4DCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Post-4DCT Viewing, Post-Arthroscopy

Secondary outcomes (1)
  1. 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.

    Measured: Baseline and 1 Year Post-Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start23 Oct 2017
  3. Primary completion23 Jan 2023
  4. Study completion23 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03193996
Sponsor's protocol ID
17-001279
Other IDs
1R01AR071338-01
Acronym
4DCT
Status last verified
Jun 2024
First submitted
15 Jun 2017
Last updated
5 Jun 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 4DCT in people with Scapholunate Interosseous Ligament Injury, run by Kristin Zhao, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan. (time frame: Baseline, Post-4DCT Viewing, Post-Arthroscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.

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