4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Status: | Enrolling by invitation |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/17/2018 |
Start Date: | October 12, 2017 |
End Date: | April 15, 2022 |
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.
current invasive diagnostic tests for ligament injuries of the wrist.
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.
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.
Inclusion Criteria:
1. unilateral scapholunate instability
2. point tenderness over the dorsal aspect of the scapholunate joint
3. one or more of the following symptoms:
- positive Watson shift sign (Watson et al., J Hand Surg Am, 1988; 13:657-60);
- loss of grip strength;
- suspected pathology on previous fluoroscopy or MRI;
- history of a fall on an outstretched hand
4. absence of symptoms on the contralateral wrist on physical exam
Exclusion Criteria:
1. obesity (BMI > 32)
2. previously-diagnosed rheumatological conditions or connective tissue diseases
3. inability to be appropriately positioned in the scanner for the imaging
4. congenital malformations of the wrist or forearm
5. diagnosed wrist osteoarthritis
6. age under 18 or over 60
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