In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

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)?

Study Overview

• Status: Terminated
• Conditions: Scapholunate Ligament Tear
• Intervention / Treatment: Device: CT scan; Device: Fluoroscopy Scan

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Scapholunate tear; Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken	Device: CT scan; A CT scan of the wrist; Device: Fluoroscopy Scan; A fluoroscopy scan of the wrist.
ACTIVE_COMPARATOR: Control Wrist; Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.	Device: CT scan; A CT scan of the wrist; Device: Fluoroscopy Scan; A fluoroscopy scan of the wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): April 27, 2018
• Study Completion (ACTUAL): April 27, 2018

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (ESTIMATE): January 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2015P001271