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In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03017040
Enrollment
1
Registered
2017-01-11
Start date
2015-09-30
Completion date
2018-04-27
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scapholunate Ligament Tear

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.

Interventions

DEVICECT scan

A CT scan of the wrist

DEVICEFluoroscopy Scan

A fluoroscopy scan of the wrist.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Participant flow

Participants by arm

ArmCount
Participants With Unilateral Scapholunate Tear
All subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. The injured wrist will enroll in the SL tear group and the uninjured wrist as the control wrist. CT scan: A CT scan of the wrist Fluoroscopy Scan: A fluoroscopy scan of the wrist.
1
Total1

Baseline characteristics

CharacteristicParticipants With Unilateral Scapholunate Tear
Age, Continuous47 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
1 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 10 / 1
other
Total, other adverse events
0 / 10 / 1
serious
Total, serious adverse events
0 / 10 / 1

Outcome results

Primary

DASH Questionnaire

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

Time frame: at enrollment

Population: The paper-based questionnaire was not scored and tallied, thus not analyzed.

Primary

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.

Time frame: at enrollment

Population: The paper-based questionnaire was not scored and tallied, thus not analyzed.

Primary

SF-12 Patient Questionnaire

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

Time frame: at enrollment

Population: The paper-based questionnaire was not scored and tallied, thus not analyzed.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026