Non-displaced Scaphoid FracturesNCT00916539
Cast Immobilization for Non-Displaced Scaphoid Fractures
A study testing Cast that immobilizes the thumb and Cast that does not immobilize the thumb in people with Non-displaced Scaphoid Fractures, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-displaced Scaphoid Fractures
- What is being tested?
- Cast that immobilizes the thumb and Cast that does not immobilize the thumb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2013
- 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
- 18 years or older
- Isolated fracture of the scaphoid
- No displacement of the scaphoid fracture on CT scan
Who cannot join
- Associated ipsilateral ligament injury or fracture
- Pregnant Patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusettes General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb
This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.
- Conditions
- Non-displaced Scaphoid Fractures
- Being tested
- Cast that immobilizes the thumb, Cast that does not immobilize the thumb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast that immobilizes the thumbDevice
Cast that immobilizes the thumb
Cast that does not immobilize the thumbDevice
Cast that does not immobilize the thumb
| Study group | Role | What they receive |
|---|---|---|
| Cast that immobilizes the thumb | Experimental | Cast that immobilizes the thumb Receives: Device: Cast that immobilizes the thumb |
| Cast that does not immobilize the thumb | Active comparator | Cast that does not immobilize the thumb Receives: Device: Cast that does not immobilize the thumb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Union
The investigators looked at the extent of fracture union after immobilization.
Measured: 10 weeks
Secondary outcomes (8)
DASH Questionnaire
This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability).
Measured: 6 months
Modified Mayo Wrist Score
The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.
Measured: 6 months
Grip Strength
Measured: 6 months
Visual Analog Scale for Pain
The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain.
Measured: 6 months
Range of Motion: Flexion
Range of motion measures the ability to move the wrist joint after injury.
Measured: 6 months
Range of Motion: Extension
Range of motion measures the ability to move the wrist joint after injury.
Measured: 6 months
Range of Motion: Ulnar Deviation
Range of motion measures the ability to move the wrist joint after injury.
Measured: 6 months
Range of Motion: Radial Deviation
Range of motion measures the ability to move the wrist joint after injury.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2012
- Study completionDec 2013
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 Non-displaced Scaphoid FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David C Ring, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916539
- Sponsor's protocol ID
- 2006P-001424
- Other IDs
- IRB 2006p001424
- Status last verified
- Mar 2017
- First submitted
- 5 Jun 2009
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb
- ClinicalTrials.gov ID
- NCT00916539
- Acronym / sponsor ID
- 2006P-001424
- Conditions
- Non-displaced Scaphoid Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Posted 12 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast that immobilizes the thumb | Experimental | Device: Cast that immobilizes the thumbCast that immobilizes the thumb |
| Cast that does not immobilize the thumb | Active comparator | Device: Cast that does not immobilize the thumbCast that does not immobilize the thumb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Isolated fracture of the scaphoid
- No displacement of the scaphoid fracture on CT scan
Key exclusion criteria (2 listed)
- Associated ipsilateral ligament injury or fracture
- Pregnant Patient
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 |
|---|---|---|
| Cast that immobilizes the thumbCast that immobilizes the thumb | Device | Cast that immobilizes the thumb |
| Cast that does not immobilize the thumbCast that does not immobilize the thumb | Device | Cast that does not immobilize the thumb |
Primary outcome
Extent of Union
Time frame: 10 weeks
The investigators looked at the extent of fracture union after immobilization.
8 secondary outcomes
DASH Questionnaire
Time frame: 6 months
Modified Mayo Wrist Score
Time frame: 6 months
Grip Strength
Time frame: 6 months
Visual Analog Scale for Pain
Time frame: 6 months
Range of Motion: Flexion
Time frame: 6 months
Range of Motion: Extension
Time frame: 6 months
Range of Motion: Ulnar Deviation
Time frame: 6 months
Range of Motion: Radial Deviation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
David C Ring, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast that immobilizes the thumb and Cast that does not immobilize the thumb in people with Non-displaced Scaphoid Fractures, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 12 Apr 2017). 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?
Extent of Union (time frame: 10 weeks). 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 12 Apr 2017.