Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not enough research staff
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scapholunate tear | Experimental | Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken |
|
| Control Wrist | Active Comparator | Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Device | A CT scan of the wrist |
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neal Chen, MD | Massachusetts General Hospital | Principal Investigator |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Scapholunate Tear | Subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists. CT scan: A CT scan of the wrist Fluoroscopy Scan: A fluoroscopy scan of the wrist. |
| FG001 | Control Wrist | Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists. CT scan: A CT scan of the wrist Fluoroscopy Scan: A fluoroscopy scan of the wrist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject accounts for scapholunate tear and control wrist, i.e., one subject enrolled for two study wrists.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The paper-based questionnaire was not scored and tallied, thus not analyzed. | Posted | at enrollment |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scapholunate Tear | Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken CT scan: A CT scan of the wrist Fluoroscopy Scan: A fluoroscopy scan of the wrist. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal Chen | Massachusetts General Hospital | 617-726-4700 | nchen1@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2017 | Jun 13, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluoroscopy Scan |
| Device |
A fluoroscopy scan of the wrist. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | SF-12 Patient Questionnaire | The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities | The paper-based questionnaire was not scored and tallied, thus not analyzed. | Posted | at enrollment |
|
|
| Primary | DASH Questionnaire | The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury. | The paper-based questionnaire was not scored and tallied, thus not analyzed. | Posted | at enrollment |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control Wrist | Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. CT scan: A CT scan of the wrist Fluoroscopy Scan: A fluoroscopy scan of the wrist. | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |