Metacarpal FracturesNCT02547181
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
A study testing Behavioral Modification and Splint in people with Metacarpal Fractures, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metacarpal Fractures
- What is being tested?
- Behavioral Modification and Splint
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of true boxer's fracture
- Candidate for either supportive splinting or tensor bandage
- Speaking, read and write English
Who cannot join
- Prior surgical treatment for boxer's fractures or other hand conditions.
- Concurrent hand/wrist injury
Trial locations and contacts
1 site in 1 country.
Catherine McMillan, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Catherine McMillan, MSc, catherine.mcmillan@sunnybrook.ca
About this study
This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications.
Read the detailed description
After initial treatment in the emergency department, patients with boxer's features are referred to the division of plastic and reconstructive surgery at Sunnybrook hospital. During initial consultation with the hand surgeon, treatment is chosen. Patients are follow-up with their hand surgeon at 4-, 8-, and 12--week intervals.
Supportive splinting: Patient's are given a removable plaster/fiberglass splint with a tensor bandage underneath.
Behavioral Modifications: Patients are not splinted, but provided a tensor bandage. Patients are instructed on specific behaviours to prevent movement of the injured part of the hand.
The purpose of the study is to compare pain and short-term hand function in patients who undergo supportive splinting compared to patients who undergo behavioral modifications treatment only to see which option is associated with shorter functional recovery and which option is associated with less pain during the first 4 weeks after initial treatment.
On follow-up appointments at 4, 8,and 12 weeks, as well as initial consultation with the hand surgeon, participants will be asked to perform a grip strength test with a Jamal Hydraulic hand Dynanometer. Participants will be asked to fill out a Brief Michigan Hand Questionnaire along with the grip strength test as well as quick demographics survey at initial consultation with the hand surgeon. After the 12-week follow up appointment, study participation will end.
If a patient is unable to follow-up with the hand surgeon, the Brief Michigan Hand Questionnaire will be done via phone whenever is most convenient for the patient. It's anticipated that about 40 people will participate in this study at a single centre in Toronto.
- Conditions
- Metacarpal Fractures
- Being tested
- Behavioral Modification, Splint
- Keywords
- Fracture, Follow-up, metacarpal
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ModificationBehavioural
Patient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand.
SplintBehavioural
fibreglass splint
| Study group | Role | What they receive |
|---|---|---|
| Splint | Experimental | Patients will be provided instructed to use a tensor bandage as well as specific behaviours to prevent movement of the injured part of the hand. Receives: Behavioral: Splint |
| Behavioral Modification | Experimental | Patients are given a removable plaster/fiberglass splint with a tensor bandage underneath Receives: Behavioral: Behavioral Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
Measured: 4 weeks
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
Measured: 8 weeks
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
Measured: 12 weeks
Secondary outcomes (3)
Grip strength
measured using Dynamometer
Measured: 4 weeks
Grip strength
measured using Dynamometer
Measured: 8 weeks
Grip strength
measured using Dynamometer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacarpal FracturesStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547181
- Sponsor's protocol ID
- 341-2014
- Status last verified
- Oct 2016
- First submitted
- 6 Mar 2015
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
- ClinicalTrials.gov ID
- NCT02547181
- Acronym / sponsor ID
- 341-2014
- Conditions
- Metacarpal Fractures
- Keywords
- Fracture, Follow-up, metacarpal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications.
Detailed description
After initial treatment in the emergency department, patients with boxer's features are referred to the division of plastic and reconstructive surgery at Sunnybrook hospital. During initial consultation with the hand surgeon, treatment is chosen. Patients are follow-up with their hand surgeon at 4-, 8-, and 12--week intervals.
Supportive splinting: Patient's are given a removable plaster/fiberglass splint with a tensor bandage underneath.
Behavioral Modifications: Patients are not splinted, but provided a tensor bandage. Patients are instructed on specific behaviours to prevent movement of the injured part of the hand.
The purpose of the study is to compare pain and short-term hand function in patients who undergo supportive splinting compared to patients who undergo behavioral modifications treatment only to see which option is associated with shorter functional recovery and which option is associated with less pain during the first 4 weeks after initial treatment.
On follow-up appointments at 4, 8,and 12 weeks, as well as initial consultation with the hand surgeon, participants will be asked to perform a grip strength test with a Jamal Hydraulic hand Dynanometer. Participants will be asked to fill out a Brief Michigan Hand Questionnaire along with the grip strength test as well as quick demographics survey at initial consultation with the hand surgeon. After the 12-week follow up appointment, study participation will end.
If a patient is unable to follow-up with the hand surgeon, the Brief Michigan Hand Questionnaire will be done via phone whenever is most convenient for the patient. It's anticipated that about 40 people will participate in this study at a single centre in Toronto.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splint | Experimental | Behavioral: SplintPatients will be provided instructed to use a tensor bandage as well as specific behaviours to prevent movement of the injured part of the hand. |
| Behavioral Modification | Experimental | Behavioral: Behavioral ModificationPatients are given a removable plaster/fiberglass splint with a tensor bandage underneath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of true boxer's fracture
- Candidate for either supportive splinting or tensor bandage
- Speaking, read and write English
Key exclusion criteria (2 listed)
- Prior surgical treatment for boxer's fractures or other hand conditions.
- Concurrent hand/wrist injury
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 |
|---|---|---|
| Behavioral ModificationPatient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand. | Behavioural | Behavioral Modification |
| Splintfibreglass splint | Behavioural | Splint |
Primary outcome
hand function
Time frame: 4 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
hand function
Time frame: 8 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
hand function
Time frame: 12 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
3 secondary outcomes
Grip strength
Time frame: 4 weeks
Grip strength
Time frame: 8 weeks
Grip strength
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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.
Catherine McMillan, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Modification and Splint in people with Metacarpal Fractures, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 24 Oct 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine McMillan, MSc (Catherine.mcmillan@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand function (time frame: 4 weeks). 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 24 Oct 2016.