Scapholunate Ligament TearNCT03017040
In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
A study testing CT scan and Fluoroscopy Scan in people with Scapholunate Ligament Tear, run by Massachusetts General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scapholunate Ligament Tear
- What is being tested?
- CT scan and Fluoroscopy Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 27 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging
Who cannot join
- Patients with a partial thickness scapholunate ligament tear
- Patients with radiographic arthrosis
- Patients with prior wrist injury
- Pregnant women
About this study
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)?
Read the 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.
- Conditions
- Scapholunate Ligament Tear
- Being tested
- CT scan, Fluoroscopy Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDevice
A CT scan of the wrist
Fluoroscopy ScanDevice
A fluoroscopy scan of the wrist.
| Study group | Role | What they receive |
|---|---|---|
| Scapholunate tear | Experimental | Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken Receives: Device: CT scan; Device: Fluoroscopy Scan |
| Control Wrist | Active comparator | Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. Receives: Device: CT scan; Device: Fluoroscopy Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment
SF-12 Patient Questionnaire
The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities
Measured: at enrollment
DASH Questionnaire
The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startSep 2015
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Why it stopped: Not enough research staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scapholunate Ligament TearStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017040
- Sponsor's protocol ID
- 2015P001271
- Status last verified
- Aug 2019
- First submitted
- 7 Dec 2016
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
- ClinicalTrials.gov ID
- NCT03017040
- Acronym / sponsor ID
- 2015P001271
- Conditions
- Scapholunate Ligament Tear
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough research staff
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 17 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapholunate tear | Experimental | Device: CT scan, Device: Fluoroscopy ScanSubjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken |
| Control Wrist | Active comparator | Device: CT scan, Device: Fluoroscopy ScanSubjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging
Key exclusion criteria (4 listed)
- Patients with a partial thickness scapholunate ligament tear
- Patients with radiographic arthrosis
- Patients with prior wrist injury
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanA CT scan of the wrist | Device | Control Wrist, Scapholunate tear |
| Fluoroscopy ScanA fluoroscopy scan of the wrist. | Device | Control Wrist, Scapholunate tear |
Primary outcome
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.
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
DASH Questionnaire
Time frame: at enrollment
The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Chen, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and Fluoroscopy Scan in people with Scapholunate Ligament Tear, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Wrist Evaluation (PRWE) (time frame: at enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.