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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

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Equivalency of 4DCT-based treatment plan to arthroscopic-based treatment plan, determined by surgeon evaluation and comparison. [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT03193996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Official Title  ICMJE 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Scapholunate Interosseous Ligament Injury
Intervention  ICMJE Device: 4DCT
4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
Study Arms  ICMJE SLIL Injury
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
Intervention: Device: 4DCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193996
Other Study ID Numbers  ICMJE 17-001279
1R01AR071338-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kristin Zhao, PhD, Mayo Clinic
Study Sponsor  ICMJE Kristin Zhao, PhD
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Kristin D. Zhao, Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP