N/A
N=29
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Scapholunate Interosseous Ligament Injury
Bottom Line
View on ClinicalTrials.gov: NCT03193996 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan. — 5; 14; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4DCT (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kristin Zhao, PhD
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan. |
5; 14; 11 | — |
| SECONDARY Subject Perception of Surgical Outcome |
-12.5; -4.5; -20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03193996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.