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

Primary Purpose

Scapholunate Interosseous Ligament Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4DCT
Sponsored by
Kristin Zhao, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Scapholunate Interosseous Ligament Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SLIL Injury

Arm Description

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

Outcomes

Primary Outcome Measures

Equivalency of 4DCT-based treatment plan to arthroscopic-based treatment plan, determined by surgeon evaluation and comparison, VAS, and PRWE.
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

Subject perception of surgical outcome
Baseline and one year post-surgery Total PRWE Score and composite change in VAS score will measure patient perception of change.

Full Information

First Posted
June 15, 2017
Last Updated
February 27, 2023
Sponsor
Kristin Zhao, PhD
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03193996
Brief Title
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Acronym
4DCT
Official Title
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scapholunate Interosseous Ligament Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SLIL Injury
Arm Type
Other
Arm Description
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
Intervention Type
Device
Intervention Name(s)
4DCT
Intervention Description
4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
Primary Outcome Measure Information:
Title
Equivalency of 4DCT-based treatment plan to arthroscopic-based treatment plan, determined by surgeon evaluation and comparison, VAS, and PRWE.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Subject perception of surgical outcome
Description
Baseline and one year post-surgery Total PRWE Score and composite change in VAS score will measure patient perception of change.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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