FractureNCT02441790
Early Range of Motion in 5th Metacarpal Fracture
A study testing Early Active Range of Motion and Standard Immobilization in people with Fracture, run by McMaster University at 1 site in Canada.
Trial summary
Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- What is being tested?
- Early Active Range of Motion and Standard Immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jun 2017
- 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
- Age equal or greater than 18 years
- Fifth metacarpal neck fracture, 9 or fewer days since injury
- Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site.
- No angulation or malrotation
- No clinical fracture shortening (ie. Inability to extend fifth digit)
- Non-operative treatment
- Volar or ulnar gutter splint (MCP flexed, IPs extended)
Who cannot join
- Metabolic bone disease
- "Open fracture" with soft tissue loss overlying fracture site
- Tendon injury
- Neurovascular injury
- Clinical rotatory malalignment
- Fracture shortening demonstrated by "pseudoclawing"
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- Other fracture in the ipsilateral upper extremity
- Any operative indication
- Previous fracture to the involved fifth ray
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Range of Motion in 5th Metacarpal Fracture: A Randomized Controlled Trial
Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.
Read the detailed description
Fractures of the fifth metacarpal neck ("boxer's fractures"), are the most common injury to the upper extremity. They are the result of axial force on a flexed metacarpalphalangeal (MCP) joint. Typically, they are caused by striking a hard object with a closed fist, breaking the knuckle on the "little" finger. Restoring hand function quickly and reliably for return to work and/or activity is of utmost importance. These patients are a significant labour force demographic. Since the injury is not characteristically sustained at work, "return-to-work"is an important patient consideration for lost wages. Treatment for fractures of the fifth metacarpal neck is typically non-operative. In the absence of urgent operative indications (ie. "open fractures" or contamination), non-operative management is initiated. Closed reduction is performed with local anaesthesia and manual manipulation. A splint is then applied. Repeat x-rays are obtained to determine positioning. If anatomic alignment is stable, no surgery is indicated and the patient remains splinted for 3-4 weeks. "Early active range of motion" (EAROM) refers to actively moving the fractured digit once fracture callus has begun formation at 3 days. In practice, EAROM begins at 3-14 days.It involves controlled, active tendon glide exercises where the patient attempts to move joints in the injured hand. This motion is perpendicular to the fractures pattern, applying a compressive force to the fracture. From basic science models, compressive forces of EAROM improve rate of bone callus differentiation,early healing,fracture angulation and load bearing.This study aims to translate these basic science concepts to practice.
- Conditions
- Fracture
- Being tested
- Early Active Range of Motion, Standard Immobilization
- Keywords
- 5th metacarpal, EAROM, standard immobilization, Boxer's Fracture, hand function, DASH, trauma
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Active Range of MotionBehavioural
3-9 days
Standard ImmobilizationBehavioural
21-27 days
| Study group | Role | What they receive |
|---|---|---|
| Early Active Range of Motion | Experimental | Early Active Range of Motion (EAROM) 3-9 days following hand fracture Receives: Behavioral: Early Active Range of Motion |
| Standard Immoblization | Active comparator | Standard immobilization with plaster splint for 21-27 following hand fracture Receives: Behavioral: Standard Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Measured: 6 weeks
Secondary outcomes (1)
HR-QOL
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Recruitment Difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Michael James Cooper, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441790
- Sponsor's protocol ID
- NIF-2013-07
- Status last verified
- Dec 2017
- First submitted
- 1 May 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Range of Motion in 5th Metacarpal Fracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02441790
- Acronym / sponsor ID
- NIF-2013-07
- Conditions
- Fracture
- Keywords
- 5th metacarpal, EAROM, standard immobilization, Boxer's Fracture, hand function, DASH, trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment Difficulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- May 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 May 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.
Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.
Detailed description
Fractures of the fifth metacarpal neck ("boxer's fractures"), are the most common injury to the upper extremity. They are the result of axial force on a flexed metacarpalphalangeal (MCP) joint. Typically, they are caused by striking a hard object with a closed fist, breaking the knuckle on the "little" finger. Restoring hand function quickly and reliably for return to work and/or activity is of utmost importance. These patients are a significant labour force demographic. Since the injury is not characteristically sustained at work, "return-to-work"is an important patient consideration for lost wages. Treatment for fractures of the fifth metacarpal neck is typically non-operative. In the absence of urgent operative indications (ie. "open fractures" or contamination), non-operative management is initiated. Closed reduction is performed with local anaesthesia and manual manipulation. A splint is then applied. Repeat x-rays are obtained to determine positioning. If anatomic alignment is stable, no surgery is indicated and the patient remains splinted for 3-4 weeks. "Early active range of motion" (EAROM) refers to actively moving the fractured digit once fracture callus has begun formation at 3 days. In practice, EAROM begins at 3-14 days.It involves controlled, active tendon glide exercises where the patient attempts to move joints in the injured hand. This motion is perpendicular to the fractures pattern, applying a compressive force to the fracture. From basic science models, compressive forces of EAROM improve rate of bone callus differentiation,early healing,fracture angulation and load bearing.This study aims to translate these basic science concepts to practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Active Range of Motion | Experimental | Behavioral: Early Active Range of MotionEarly Active Range of Motion (EAROM) 3-9 days following hand fracture |
| Standard Immoblization | Active comparator | Behavioral: Standard ImmobilizationStandard immobilization with plaster splint for 21-27 following hand fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age equal or greater than 18 years
- Fifth metacarpal neck fracture, 9 or fewer days since injury
- Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site.
- No angulation or malrotation
- No clinical fracture shortening (ie. Inability to extend fifth digit)
Key exclusion criteria (9 listed)
- Metabolic bone disease
- "Open fracture" with soft tissue loss overlying fracture site
- Tendon injury
- Neurovascular injury
- Clinical rotatory malalignment
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 |
|---|---|---|
| Early Active Range of Motion3-9 days | Behavioural | Early Active Range of Motion |
| Standard Immobilization21-27 days | Behavioural | Standard Immoblization |
Primary outcome
Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time frame: 6 weeks
1 secondary outcome
HR-QOL
Time frame: 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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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.
Michael James Cooper, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Active Range of Motion and Standard Immobilization in people with Fracture, run by McMaster University 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 12 Dec 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure (time frame: 6 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 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.