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

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ClinicalTrials.gov Identifier: NCT03193996
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kristin Zhao, PhD, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Scapholunate Interosseous Ligament Injury Device: 4DCT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
SLIL Injury
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
Device: 4DCT
4DCT will be used to assess the location of the torn scapholunate interosseus ligament.




Primary Outcome Measures :
  1. Equivalency of 4DCT-based treatment plan to arthroscopic-based treatment plan, determined by surgeon evaluation and comparison, VAS, and PRWE. [ Time Frame: 2 years ]
    Baseline, Post-4DCT Viewing, Post-Arthroscopy estimates or observations of tear location, completeness of tear, Geissler stage, EWAS stage, and treatment indication will be compared against one another. At one-year post surgery, subject surgical outcomes will be compared to the standard outcome of patients who undergo only a routine arthroscopy before surgery.


Secondary Outcome Measures :
  1. Subject perception of surgical outcome [ Time Frame: 2 years ]
    Baseline and one year post-surgery Total PRWE Score and composite change in VAS score will measure patient perception of change.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193996


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Kristin Zhao, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Kristin D. Zhao, Ph.D. Mayo Clinic

Additional Information:
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Responsible Party: Kristin Zhao, PhD, Assistant Professor of Biomedical Engineering, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03193996     History of Changes
Other Study ID Numbers: 17-001279
1R01AR071338-01 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Wounds and Injuries