Scapholunate Interosseous Ligament Injury4DCTNCT03193996
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
A study testing 4DCT in people with Scapholunate Interosseous Ligament Injury, run by Kristin Zhao, PhD at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scapholunate Interosseous Ligament Injury
- What is being tested?
- 4DCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Being tested
- 4DCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DCTDevice
4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
| Study group | Role | What they receive |
|---|---|---|
| SLIL Injury | Other | Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy. Receives: Device: 4DCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 1 Year Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start23 Oct 2017
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scapholunate Interosseous Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Zhao, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin D. Zhao, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193996
- Sponsor's protocol ID
- 17-001279
- Other IDs
- 1R01AR071338-01
- Acronym
- 4DCT
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2017
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
- ClinicalTrials.gov ID
- NCT03193996
- Acronym / sponsor ID
- 4DCT / 17-001279
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kristin Zhao, PhDUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLIL Injury | Other | Device: 4DCTSurgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4DCT4DCT will be used to assess the location of the torn scapholunate interosseus ligament. | Device | SLIL Injury |
Primary outcome
Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.
Time frame: Baseline, Post-4DCT Viewing, Post-Arthroscopy
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.
1 secondary outcome
Subject Perception of Surgical Outcome
Time frame: Baseline and 1 Year Post-Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Scapholunate Interosseous Ligament Injury
Active, not recruitingObservational study
Comparison of Strength, Weight Bearing, Proprioception, Reaction Time and Function in Scapholunate Instability
Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin D. Zhao, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4DCT in people with Scapholunate Interosseous Ligament Injury, run by Kristin Zhao, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan. (time frame: Baseline, Post-4DCT Viewing, Post-Arthroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.