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In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017040
Recruitment Status : Terminated (Not enough research staff)
First Posted : January 11, 2017
Results First Posted : September 17, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, 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)?

Condition or disease Intervention/treatment Phase
Scapholunate Ligament Tear Device: CT scan Device: Fluoroscopy Scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
Actual Study Start Date : September 2015
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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.




Primary Outcome Measures :
  1. Patient Rated Wrist Evaluation (PRWE) [ Time Frame: at enrollment ]
    The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.

  2. SF-12 Patient Questionnaire [ Time Frame: at enrollment ]
    The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities

  3. DASH Questionnaire [ Time Frame: at enrollment ]
    The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017040


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Neal Chen, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Neal Chung-Jen Chen, Massachusetts General Hospital:
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Responsible Party: Neal Chung-Jen Chen, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03017040    
Other Study ID Numbers: 2015P001271
First Posted: January 11, 2017    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: August 14, 2019
Last Verified: August 2019