ClinicalTrials.gg
CompletedNCT031939964DCTUpdated Jun 5, 2024Results posted

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

An interventional study of 4DCT in Scapholunate Interosseous Ligament Injury, sponsored by Kristin Zhao, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Kristin Zhao, PhD · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Scapholunate Interosseous Ligament Injury
03

In context

Lead sponsor

Kristin Zhao, PhD is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Other
    SLIL Injury

    Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.

    Device: 4DCT

Interventions

  • Device4DCT

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline, Post-4DCT Viewing, Post-Arthroscopy

Secondary outcomes

  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.

    Time frame: Baseline and 1 Year Post-Surgery

07

Results

Posted Jun 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneSLIL Injury
Started29
Completed16
Not completed13
Withdrew: Withdrawal by subject4
Withdrew: Lost to follow-up4
Withdrew: Physician decision2
Withdrew: Pregnancy1
Withdrew: Subject did not proceed to reconstructive surgery.1
Withdrew: Complicating disease1

Outcome measures

PrimaryEquivalency 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.

Time frame:
Baseline, Post-4DCT Viewing, Post-Arthroscopy
Reported as:
Count of participants · Participants
Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.
ParticipantsSLIL Injury
4DCT changed suspected Geissler stage5
Agreement in Geissler stage between arthroscopy and 4DCT.14
Agreement in Geissler stage between arthroscopy and clinical suspicion pre-4DCT11
SecondarySubject 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.

Time frame:
Baseline and 1 Year Post-Surgery
Reported as:
Median · score on a scale
Subject Perception of Surgical Outcome
score on a scaleSLIL Injury
Pain domain change between baseline and 1-year post surgery-12.5 (-18 to -6)
Functional impairment change between baseline and 1-year post surgery-4.5 (-7.5 to -2)
Total PRWE score change between baseline and 1-year post surgery-20 (-24.3 to -8.5)

Adverse events

Collected over At baseline and 1-year post surgery. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SLIL Injury0/29 (0%)0/29 (0%)0/29 (0%)

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)SLIL Injury
Mean41.7 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)SLIL Injury
Female5
Male24
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SLIL Injury
Hispanic or Latino0
Not Hispanic or Latino28
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SLIL Injury
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White27
More than one race0
Unknown or Not Reported2
Region of Enrollment
Region of Enrollment(participants)SLIL Injury
United States29
08

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Jan 2023, 63 months.

Results were first posted in Jun 2024, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2017
First posted
Jun 21, 2017
StartActual
Oct 23, 2017
Primary completionActual
Jan 23, 2023
CompletionActual
Jan 23, 2023
Results first posted
Jun 5, 2024
Last update
Jun 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03193996
Lead sponsor
Kristin Zhao, PhD
Responsible party
Kristin Zhao, PhD (Assistant Professor of Biomedical Engineering, Mayo Clinic) — Sponsor-investigator
First posted
Jun 21, 2017
Start date
Oct 23, 2017
Primary completion
Jan 23, 2023
Completion
Jan 23, 2023
Results posted
Jun 5, 2024
Last update
Jun 5, 2024

Study contacts

Kristin D. Zhao, Ph.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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