In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

NCT ID: NCT03017040

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-04-27

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)?

Detailed Description

In vivo kinematics of the normal wrist has been studied previously, but few studies have characterized the wrist with a SLIL injury. There are few studies evaluating validated patient-rated outcomes for patients with SLIL injury. The goal of this study would be to evaluate to what degree kinematic abnormalities affect patient-rated outcomes.

Conditions

Scapholunate Ligament Tear

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Scapholunate tear

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

Group Type: EXPERIMENTAL

CT scan

Intervention Type: DEVICE

A CT scan of the wrist

Fluoroscopy Scan

Intervention Type: DEVICE

A fluoroscopy scan of the wrist.

Control Wrist

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

Group Type: ACTIVE_COMPARATOR

CT scan

Intervention Type: DEVICE

A CT scan of the wrist

Fluoroscopy Scan

Intervention Type: DEVICE

A fluoroscopy scan of the wrist.

Interventions

CT scan

A CT scan of the wrist

Intervention Type: DEVICE

Fluoroscopy Scan

A fluoroscopy scan of the wrist.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neal Chung-Jen Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015P001271

Identifier Type: -

Identifier Source: org_study_id