Bone FracturesNCT01759758
A Randomized Trial Comparing Conventional Plaster and Thermoplastic Splints to Treat Pediatric Boxer's Fractures
A study testing Plaster Ulnar Gutter Splint and Thermoplastic Splint in people with Bone Fractures and Splints, run by IWK Health Centre at 1 site in Canada.
Trial summary
The investigators are conducting a randomized clinical trial comparing two types of splints for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet inclusion criteria will be randomized to either Group A or B. Group A will be treated with the conventional plaster ulnar gutter splint. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Bone Fractures, Splints, Metacarpal Fracture
- What is being tested?
- Plaster Ulnar Gutter Splint and Thermoplastic Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Jun 2014
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Isolated 5th metacarpal neck fracture
- Less than 10 days from injury
Who cannot join
- Multiple Metacarpal fractures
- Significant injuries to other hand structures (tendons, nerves, major arteries)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial
The investigators are conducting a randomized clinical trial comparing two types of splints for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet inclusion criteria will be randomized to either Group A or B. Group A will be treated with the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded thermoplastic hand-based splint. The thermoplastic splint will provide support of the metacarpal but does not immobilize the patient's wrist or interphalangeal joints.
Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated better than the other and will the compliance be different between the two groups?
Read the detailed description
Nearly all Boxer's fractures are treated without surgery using a splint to keep part or all of the hand from moving (immobilization). There are several acceptable methods of immobilization used by hand surgeons, using splints of different sizes and materials for variable periods of time(1-6).
A recent systematic review from The Cochrane Collaboration found the current data to be inconclusive with regards to the optimal immobilization technique and highlighted the need for further studies(2). Specifically, it was recommended that future studies include functional outcome measures, timing of return to work, complications, pain scores, and an economic analysis.
The current practice at the investigators' institution is for patients to be splinted in a plaster ulnar gutter splint, in the Emergency Department and referred to the next available plastic surgery clinic. If needed, a closed reduction would be performed in clinic, if there was a significant angulation (greater than 45 degrees) or any clinical rotation deformity. The most common method of immobilization involves placing the wrist, ring finger and little finger all the way from the fingertips to the mid-forearm in molded plaster called an ulnar gutter splint. The splint is left on 24 hours a day for 3 to 4 weeks and then removed in the clinic.
Many patients find it difficult to keep the splint on for the full 3 to 4 weeks for a number of reasons. The plaster needs to stay dry, making it awkward to bathe. The splint can also get loose and rub as the swelling around the fracture gets better. The splint can also start to smell because sweat builds up under it. Some patients find the plaster material heavy, making it difficult to wear. Finally, many patients are self-conscious about the appearance of the splint and remove it for this reason alone. In the investigators' experience, up to 1 out of 5 patients will remove the splint on their own against doctor's orders for one reason or another. When patients do follow instructions and keep the splint on 24 hours a day for 3 to 4 weeks, this can lead to joint stiffness when the splint is removed. Some patients may even require physiotherapy to regain their normal finger movement and grip strength.
It is unknown if the ulnar gutter splint is really the best way to immobilize the hand after a Boxer's fracture. It is unknown what material is best for making the splint, whether it is truly necessary to keep the entirety of the wrist and ring and little fingers still, and for how long the hand and fingers should be kept still. Most surgeons recommend patients wear a splint for 3 to 4 weeks.
The investigators would like to determine if a smaller splint made of more durable, lighter moldable plastic that allows earlier movement of the hand and fingers while still keeping the fracture from moving gives the same result as the commonly used ulnar gutter splint.
Functional Hand Based Splint (Thermoplastic Splint) The functional hand-based splint is made of custom molded hard plastic and is fitted over the hand only. A thermoplastic splint is made from plastic that is heated and custom-fitted to the subject's hand, which hardens when it cools. This thermoplastic splint is custom fitted by an occupational therapist such that all joints are free to move. The splint does not limit the patient from moving their wrist or fingers while wearing it. It is custom molded such that it fits snuggly over the patient's hand and holds the fracture in a stable position.
Several adult studies have found this type of custom molded splint superior to either surgical treatment and/or plaster splint immobilization because it resulted in less stiffness, better movement after splint removal, and no increased pain (4-7). The investigators are not aware of any comparative studies done in pediatric patients.
Compliance Patient compliance for wearing their splint for the prescribed during can be a problem. At the investigators' institution, there is a non-compliance rate of approximately 15 to 20 % for Boxer's fracture patients. The investigators hypothesize that the hand-based splint will be better tolerated by patients and therefore result in a higher rate of compliance for the prescribed duration that the plaster splint. Also, the thermoplastic splint will not be damaged if it gets wet, which may translate into fewer additional visits to the clinic or emergency department to have the splint replaced.
This study will be a randomized, single-blinded controlled trial. The randomization of the two splint types will be determined by a computer-based number generator. The patients will know what type of splint they have, but the plastic surgeons and physiotherapist who examine and test the subjects ROM and grip strength will not know the type of splint for each subject.
Patients will be randomized to one of the two groups at their first clinic visit, within 7 days of their injury. They will have their splint placed at this visit and are to wear the splint at all times for 3 weeks. Subjects will return to clinic at 1, 3, 6, and 12 weeks to be reassessed. Specified outcome measures (primary and secondary) will be tested at each visit.
- Conditions
- Bone Fractures, Splints, Metacarpal Fracture, Boxer's Fracture
- Being tested
- Plaster Ulnar Gutter Splint, Thermoplastic Splint
- Keywords
- boxer's fracture, metacarpal neck fracture, metacarpal fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster Ulnar Gutter SplintOther
Also called Conventional Plaster splint, Plaster of Paris
Patients are placed in a plaster ulnar gutter splint, molded in the safe position.
Thermoplastic SplintOther
Also called Functional brace, Moulded brace, Moulded Metacarpal brace
Thermoplastic Splint is heat moulded to the patient's hand, stabilizing the metacarpal heads, but not immobilizing any joints. This is done by our occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Plaster Ulnar Gutter Splint | Active comparator | Patients will have their hand placed in a conventional Plaster ulnar gutter splint. This immobilizes all joints of the ring and small fingers and the wrist Receives: Other: Plaster Ulnar Gutter Splint |
| Thermoplastic Splint | Experimental | Patients will be fitted with a custom molded thermoplastic splint that stabilizes the metacarpals of the injured hand but does not immobilize any joints Receives: Other: Thermoplastic Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist
Measured: up to 12 weeks
Compliance
The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed.
Measured: 3 weeks post fracture
Secondary outcomes (5)
Pain
Pain, reported on a Visual Analog Scale, will be assessed at specified time points
Measured: 1, 3, 6, and 12 weeks post fracture
Complications
Loss of fracture reduction, malunion or non-union will be monitored throughout the study
Measured: 3, 6, and 12 weeks
Validated Outcome Questionnaire
Patients will complete the Pediatric Outcomes Data Collection Instrument (PODCI) at several time points
Measured: 3, 6, and 12 weeks
Grip Strength
Patients will have their grip strength measured for the injured and non-injured hand at 6 and 12 weeks post fracture
Measured: 6 and 12 weeks
Radiographic assessment of fracture
An X-ray of the injured had will be done in 3 views. This will be assessed by one of the investigators, in a blinded fashion. They will determine the angulation and assess for evidence of bony healing
Measured: 12 weeks post fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bone 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bezuhly, IWK Health Centre
- Investigators
- Michael Bezuhly, MD, MSc, SM, Principal investigator, Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759758
- Sponsor's protocol ID
- IWK-1012457
- Status last verified
- Jan 2016
- First submitted
- 30 Dec 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunter JM, Cowen NJ. Fifth metacarpal fractures in a compensation clinic population. A report on one hundred and thirty-three cases. J Bone Joint Surg Am. 1970 Sep;52(6):1159-65. No abstract available.
PubMed 4247878Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.
PubMed 16034891Braakman M, Oderwald EE, Haentjens MH. Functional taping of fractures of the 5th metacarpal results in a quicker recovery. Injury. 1998 Jan;29(1):5-9. doi: 10.1016/s0020-1383(97)00106-x.
PubMed 9659472Harding IJ, Parry D, Barrington RL. The use of a moulded metacarpal brace versus neighbour strapping for fractures of the little finger metacarpal neck. J Hand Surg Br. 2001 Jun;26(3):261-3. doi: 10.1054/jhsb.2000.0509.
PubMed 11386781Kuokkanen HO, Mulari-Keranen SK, Niskanen RO, Haapala JK, Korkala OL. Treatment of subcapital fractures of the fifth metacarpal bone: a prospective randomised comparison between functional treatment and reposition and splinting. Scand J Plast Reconstr Surg Hand Surg. 1999 Sep;33(3):315-7. doi: 10.1080/02844319950159299.
PubMed 10505445Statius Muller MG, Poolman RW, van Hoogstraten MJ, Steller EP. Immediate mobilization gives good results in boxer's fractures with volar angulation up to 70 degrees: a prospective randomized trial comparing immediate mobilization with cast immobilization. Arch Orthop Trauma Surg. 2003 Dec;123(10):534-7. doi: 10.1007/s00402-003-0580-2. Epub 2003 Aug 28.
PubMed 14639483Hansen PB, Hansen TB. The treatment of fractures of the ring and little metacarpal necks. A prospective randomized study of three different types of treatment. J Hand Surg Br. 1998 Apr;23(2):245-7. doi: 10.1016/s0266-7681(98)80186-1.
PubMed 9607671Konradsen L, Nielsen PT, Albrecht-Beste E. Functional treatment of metacarpal fractures 100 randomized cases with or without fixation. Acta Orthop Scand. 1990 Dec;61(6):531-4. doi: 10.3109/17453679008993576.
PubMed 2281761Sawyer JR, Ivie CB, Huff AL, Wheeler C, Kelly DM, Beaty JH, Canale ST. Emergency room visits by pediatric fracture patients treated with cast immobilization. J Pediatr Orthop. 2010 Apr-May;30(3):248-52. doi: 10.1097/BPO.0b013e3181d213bc.
PubMed 20357591Strub B, Schindele S, Sonderegger J, Sproedt J, von Campe A, Gruenert JG. Intramedullary splinting or conservative treatment for displaced fractures of the little finger metacarpal neck? A prospective study. J Hand Surg Eur Vol. 2010 Nov;35(9):725-9. doi: 10.1177/1753193410377845. Epub 2010 Jul 21.
PubMed 20659966Hofmeister EP, Kim J, Shin AY. Comparison of 2 methods of immobilization of fifth metacarpal neck fractures: a prospective randomized study. J Hand Surg Am. 2008 Oct;33(8):1362-8. doi: 10.1016/j.jhsa.2008.04.010.
PubMed 18929202Lerman JA, Sullivan E, Barnes DA, Haynes RJ. The Pediatric Outcomes Data Collection Instrument (PODCI) and functional assessment of patients with unilateral upper extremity deficiencies. J Pediatr Orthop. 2005 May-Jun;25(3):405-7. doi: 10.1097/01.bpo.0000149866.80894.70.
PubMed 15832164Davison PG, Boudreau N, Burrows R, Wilson KL, Bezuhly M. Forearm-Based Ulnar Gutter versus Hand-Based Thermoplastic Splint for Pediatric Metacarpal Neck Fractures: A Blinded, Randomized Trial. Plast Reconstr Surg. 2016 Mar;137(3):908-916. doi: 10.1097/01.prs.0000479974.45051.78.
PubMed 26910672
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01759758
- Acronym / sponsor ID
- IWK-1012457
- Conditions
- Bone Fractures, Splints, Metacarpal Fracture, Boxer's Fracture
- Keywords
- boxer's fracture, metacarpal neck fracture, metacarpal fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Jan 2013 (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.
The investigators are conducting a randomized clinical trial comparing two types of splints for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet inclusion criteria will be randomized to either Group A or B. Group A will be treated with the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded thermoplastic hand-based splint. The thermoplastic splint will provide support of the metacarpal but does not immobilize the patient's wrist or interphalangeal joints.
Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated better than the other and will the compliance be different between the two groups?
Detailed description
Nearly all Boxer's fractures are treated without surgery using a splint to keep part or all of the hand from moving (immobilization). There are several acceptable methods of immobilization used by hand surgeons, using splints of different sizes and materials for variable periods of time(1-6).
A recent systematic review from The Cochrane Collaboration found the current data to be inconclusive with regards to the optimal immobilization technique and highlighted the need for further studies(2). Specifically, it was recommended that future studies include functional outcome measures, timing of return to work, complications, pain scores, and an economic analysis.
The current practice at the investigators' institution is for patients to be splinted in a plaster ulnar gutter splint, in the Emergency Department and referred to the next available plastic surgery clinic. If needed, a closed reduction would be performed in clinic, if there was a significant angulation (greater than 45 degrees) or any clinical rotation deformity. The most common method of immobilization involves placing the wrist, ring finger and little finger all the way from the fingertips to the mid-forearm in molded plaster called an ulnar gutter splint. The splint is left on 24 hours a day for 3 to 4 weeks and then removed in the clinic.
Many patients find it difficult to keep the splint on for the full 3 to 4 weeks for a number of reasons. The plaster needs to stay dry, making it awkward to bathe. The splint can also get loose and rub as the swelling around the fracture gets better. The splint can also start to smell because sweat builds up under it. Some patients find the plaster material heavy, making it difficult to wear. Finally, many patients are self-conscious about the appearance of the splint and remove it for this reason alone. In the investigators' experience, up to 1 out of 5 patients will remove the splint on their own against doctor's orders for one reason or another. When patients do follow instructions and keep the splint on 24 hours a day for 3 to 4 weeks, this can lead to joint stiffness when the splint is removed. Some patients may even require physiotherapy to regain their normal finger movement and grip strength.
It is unknown if the ulnar gutter splint is really the best way to immobilize the hand after a Boxer's fracture. It is unknown what material is best for making the splint, whether it is truly necessary to keep the entirety of the wrist and ring and little fingers still, and for how long the hand and fingers should be kept still. Most surgeons recommend patients wear a splint for 3 to 4 weeks.
The investigators would like to determine if a smaller splint made of more durable, lighter moldable plastic that allows earlier movement of the hand and fingers while still keeping the fracture from moving gives the same result as the commonly used ulnar gutter splint.
Functional Hand Based Splint (Thermoplastic Splint) The functional hand-based splint is made of custom molded hard plastic and is fitted over the hand only. A thermoplastic splint is made from plastic that is heated and custom-fitted to the subject's hand, which hardens when it cools. This thermoplastic splint is custom fitted by an occupational therapist such that all joints are free to move. The splint does not limit the patient from moving their wrist or fingers while wearing it. It is custom molded such that it fits snuggly over the patient's hand and holds the fracture in a stable position.
Several adult studies have found this type of custom molded splint superior to either surgical treatment and/or plaster splint immobilization because it resulted in less stiffness, better movement after splint removal, and no increased pain (4-7). The investigators are not aware of any comparative studies done in pediatric patients.
Compliance Patient compliance for wearing their splint for the prescribed during can be a problem. At the investigators' institution, there is a non-compliance rate of approximately 15 to 20 % for Boxer's fracture patients. The investigators hypothesize that the hand-based splint will be better tolerated by patients and therefore result in a higher rate of compliance for the prescribed duration that the plaster splint. Also, the thermoplastic splint will not be damaged if it gets wet, which may translate into fewer additional visits to the clinic or emergency department to have the splint replaced.
This study will be a randomized, single-blinded controlled trial. The randomization of the two splint types will be determined by a computer-based number generator. The patients will know what type of splint they have, but the plastic surgeons and physiotherapist who examine and test the subjects ROM and grip strength will not know the type of splint for each subject.
Patients will be randomized to one of the two groups at their first clinic visit, within 7 days of their injury. They will have their splint placed at this visit and are to wear the splint at all times for 3 weeks. Subjects will return to clinic at 1, 3, 6, and 12 weeks to be reassessed. Specified outcome measures (primary and secondary) will be tested at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaster Ulnar Gutter Splint | Active comparator | Other: Plaster Ulnar Gutter SplintPatients will have their hand placed in a conventional Plaster ulnar gutter splint. This immobilizes all joints of the ring and small fingers and the wrist |
| Thermoplastic Splint | Experimental | Other: Thermoplastic SplintPatients will be fitted with a custom molded thermoplastic splint that stabilizes the metacarpals of the injured hand but does not immobilize any joints |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Isolated 5th metacarpal neck fracture
- Less than 10 days from injury
Key exclusion criteria (2 listed)
- Multiple Metacarpal fractures
- Significant injuries to other hand structures (tendons, nerves, major arteries)
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 |
|---|---|---|
| Plaster Ulnar Gutter SplintAlso: Conventional Plaster splint, Plaster of ParisPatients are placed in a plaster ulnar gutter splint, molded in the safe position. | Other | Plaster Ulnar Gutter Splint |
| Thermoplastic SplintAlso: Functional brace, Moulded brace, Moulded Metacarpal braceThermoplastic Splint is heat moulded to the patient's hand, stabilizing the metacarpal heads, but not immobilizing any joints. This is done by our occupational therapist. | Other | Thermoplastic Splint |
Primary outcome
Range of Motion
Time frame: up to 12 weeks
The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist
Compliance
Time frame: 3 weeks post fracture
The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed.
5 secondary outcomes
Pain
Time frame: 1, 3, 6, and 12 weeks post fracture
Complications
Time frame: 3, 6, and 12 weeks
Validated Outcome Questionnaire
Time frame: 3, 6, and 12 weeks
Grip Strength
Time frame: 6 and 12 weeks
Radiographic assessment of fracture
Time frame: 12 weeks post fracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 4247878Hunter JM, Cowen NJ. Fifth metacarpal fractures in a compensation clinic population. A report on one hundred and thirty-three cases. J Bone Joint Surg Am. 1970 Sep;52(6):1159-65. No abstract available.
- Background: PubMed 16034891Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.
- Background: PubMed 9659472Braakman M, Oderwald EE, Haentjens MH. Functional taping of fractures of the 5th metacarpal results in a quicker recovery. Injury. 1998 Jan;29(1):5-9. doi: 10.1016/s0020-1383(97)00106-x.
- Background: PubMed 11386781Harding IJ, Parry D, Barrington RL. The use of a moulded metacarpal brace versus neighbour strapping for fractures of the little finger metacarpal neck. J Hand Surg Br. 2001 Jun;26(3):261-3. doi: 10.1054/jhsb.2000.0509.
- Background: PubMed 10505445Kuokkanen HO, Mulari-Keranen SK, Niskanen RO, Haapala JK, Korkala OL. Treatment of subcapital fractures of the fifth metacarpal bone: a prospective randomised comparison between functional treatment and reposition and splinting. Scand J Plast Reconstr Surg Hand Surg. 1999 Sep;33(3):315-7. doi: 10.1080/02844319950159299.
- Background: PubMed 14639483Statius Muller MG, Poolman RW, van Hoogstraten MJ, Steller EP. Immediate mobilization gives good results in boxer's fractures with volar angulation up to 70 degrees: a prospective randomized trial comparing immediate mobilization with cast immobilization. Arch Orthop Trauma Surg. 2003 Dec;123(10):534-7. doi: 10.1007/s00402-003-0580-2. Epub 2003 Aug 28.
- Background: PubMed 9607671Hansen PB, Hansen TB. The treatment of fractures of the ring and little metacarpal necks. A prospective randomized study of three different types of treatment. J Hand Surg Br. 1998 Apr;23(2):245-7. doi: 10.1016/s0266-7681(98)80186-1.
- Background: PubMed 2281761Konradsen L, Nielsen PT, Albrecht-Beste E. Functional treatment of metacarpal fractures 100 randomized cases with or without fixation. Acta Orthop Scand. 1990 Dec;61(6):531-4. doi: 10.3109/17453679008993576.
- Background: PubMed 20357591Sawyer JR, Ivie CB, Huff AL, Wheeler C, Kelly DM, Beaty JH, Canale ST. Emergency room visits by pediatric fracture patients treated with cast immobilization. J Pediatr Orthop. 2010 Apr-May;30(3):248-52. doi: 10.1097/BPO.0b013e3181d213bc.
- Background: PubMed 20659966Strub B, Schindele S, Sonderegger J, Sproedt J, von Campe A, Gruenert JG. Intramedullary splinting or conservative treatment for displaced fractures of the little finger metacarpal neck? A prospective study. J Hand Surg Eur Vol. 2010 Nov;35(9):725-9. doi: 10.1177/1753193410377845. Epub 2010 Jul 21.
- Background: PubMed 18929202Hofmeister EP, Kim J, Shin AY. Comparison of 2 methods of immobilization of fifth metacarpal neck fractures: a prospective randomized study. J Hand Surg Am. 2008 Oct;33(8):1362-8. doi: 10.1016/j.jhsa.2008.04.010.
- Background: PubMed 15832164Lerman JA, Sullivan E, Barnes DA, Haynes RJ. The Pediatric Outcomes Data Collection Instrument (PODCI) and functional assessment of patients with unilateral upper extremity deficiencies. J Pediatr Orthop. 2005 May-Jun;25(3):405-7. doi: 10.1097/01.bpo.0000149866.80894.70.
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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 Bezuhly, MD, MSc, SM principal investigator
Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie 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 Plaster Ulnar Gutter Splint and Thermoplastic Splint in people with Bone Fractures and Splints, run by IWK Health 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 2 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 13 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Range of Motion (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759758, which also lists 13 linked publications.
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 13 Jan 2016; AzTrials last refreshed its copy on 29 Oct 2026.