In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

Not Applicable

Terminated

• Conditions: Scapholunate Ligament Tear
• Interventions: Device: CT scan; Device: Fluoroscopy Scan

• Registration Number: NCT03017040
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Results First Submitted: 2018-08-13
• Results First Submitted QC: 2018-09-14
• Results First Posted: 2018-09-17
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scapholunate tear	CT scan	Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken
Scapholunate tear	Fluoroscopy Scan	Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken
Control Wrist	Fluoroscopy Scan	Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.
Control Wrist	CT scan	Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation (PRWE)	at enrollment	The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.
SF-12 Patient Questionnaire	at enrollment	The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities
DASH Questionnaire	at enrollment	The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.