N/A N=31 Basic Science

A Study to Evaluate 4DCT Controls

Wrist Ligament and Bone Disorders

Bottom Line

View on ClinicalTrials.gov: NCT04736537 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Scapholunate (SL) Gapping — 1.65; 1.64; 1.86; 1.92 millimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 4DCT (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Scapholunate (SL) Gapping	1.65; 1.64; 1.86; 1.92; 1.83; 1.79	—
PRIMARY Radioscaphoid (RS) Gapping	1.42; 1.39; 1.52; 1.50; 1.48; 1.49	—
PRIMARY Radiolunate (RL) Gapping	1.81; 1.88; 1.56; 1.79; 1.77; 1.76	—
SECONDARY Scaphotrapezium (STm) Gapping	1.06; 1.13; 1.18; 1.13; 1.14; 1.10	—
SECONDARY Scaphotrapezoid (STd) Gapping	0.97; 1.04; 1.09; 1.09; 1.26; 1.19	—
SECONDARY Trapezoitrapezoid (TmTd) Gapping	0.52; 0.55; 0.54; 0.54; 0.54; 0.55	—

Summary

The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.

Eligibility Criteria

Inclusion Criterion:

Age ≥ 18 and ≤ 60 years.
Control subjects without any history of wrist injury or disease.

Exclusion Criteria (applied to both wrists for control subjects):

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04736537). 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.