In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

NCT03017040 | Terminated Results

• 1 other identifier: 2015P001271
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators hypothesize that there is no relationship between in vivo kinematic abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries (SLIL) The secondary null hypotheses are that: There are no kinematic differences between subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the contralateral wrist without scapholunate ligament injury. The investigators aim to answer to the below questions:

• What are baseline validated outcomes for subjects with SLIL injury?
• What are baseline physical measures (range of motion, Jamar Dynamometry)?

Conditions

Scapholunate Ligament Tear

Outcome Measures

Primary Outcomes (3)

• Patient Rated Wrist Evaluation (PRWE)

  The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.

  at enrollment

• SF-12 Patient Questionnaire

  The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities

  at enrollment

• DASH Questionnaire

  The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.

  at enrollment

Study Arms (2)

Scapholunate tear

EXPERIMENTAL

Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken

Device: CT scan; Device: Fluoroscopy Scan

Control Wrist

ACTIVE COMPARATOR

Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.

Device: CT scan; Device: Fluoroscopy Scan

Interventions

CT scan DEVICE

A CT scan of the wrist

Control Wrist; Scapholunate tear

Fluoroscopy Scan DEVICE

A fluoroscopy scan of the wrist.

Control Wrist; Scapholunate tear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging

You may not qualify if:

• Patients with a partial thickness scapholunate ligament tear
• Patients with radiographic arthrosis
• Patients with prior wrist injury
• Pregnant women

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Dr. Neal Chen
• Organization: Massachusetts General Hospital

nchen1@mgh.harvard.edu

617-726-4700

Study Officials

• Neal Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: January 11, 2017
• Study Start: September 1, 2015
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: August 14, 2019
• Results First Posted: September 17, 2018

Record last verified: 2019-08