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

NCT03193996 | Completed Results FDA Device

• 2 other identifiers: 17-0012791R01AR071338-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Scapholunate Interosseous Ligament Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Post-4DCT Viewing, Post-Arthroscopy

Secondary Outcomes (1)

• Subject Perception of Surgical Outcome

  Baseline and 1 Year Post-Surgery

Study Arms (1)

SLIL Injury

OTHER

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

Device: 4DCT

Interventions

4DCT DEVICE

4DCT will be used to assess the location of the torn scapholunate interosseus ligament.

SLIL Injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristin Zhao, PhD: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinical Trials

Results Point of Contact

• Title: Tyson Scrabeck
• Organization: Mayo Clinic

scrabeck.tyson@mayo.edu

507-538-1016

Study Officials

• Kristin D. Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Biomedical Engineering

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 21, 2017
• Study Start: October 23, 2017
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)