Splints Clinical Trial
Official title:
Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial
Verified date | January 2016 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 16 Years |
Eligibility |
Inclusion Criteria: - Isolated 5th metacarpal neck fracture - Less than 10 days from injury Exclusion Criteria: - Multiple Metacarpal fractures - Significant injuries to other hand structures (tendons, nerves, major arteries) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
IWK Health Centre |
Canada,
Braakman 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. — View Citation
Hansen 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. — View Citation
Harding 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. — View Citation
Hofmeister 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. — View Citation
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. — View Citation
Konradsen 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. — View Citation
Kuokkanen HO, Mulari-Keränen 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. — View Citation
Lerman 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. — View Citation
Poolman 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;(3):CD003210. Review. — View Citation
Sawyer 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. — View Citation
Statius 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. Epub 2003 Aug 28. — View Citation
Strub 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of Motion | The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist | up to 12 weeks | No |
Primary | Compliance | The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed. | 3 weeks post fracture | No |
Secondary | Pain | Pain, reported on a Visual Analog Scale, will be assessed at specified time points | 1, 3, 6, and 12 weeks post fracture | No |
Secondary | Complications | Loss of fracture reduction, malunion or non-union will be monitored throughout the study | 3, 6, and 12 weeks | No |
Secondary | Validated Outcome Questionnaire | Patients will complete the Pediatric Outcomes Data Collection Instrument (PODCI) at several time points | 3, 6, and 12 weeks | No |
Secondary | Grip Strength | Patients will have their grip strength measured for the injured and non-injured hand at 6 and 12 weeks post fracture | 6 and 12 weeks | No |
Secondary | 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 | 12 weeks post fracture | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04544800 -
Development of Upper Aerodigestive Tract Splint
|
N/A | |
Completed |
NCT02287571 -
Skin Traction Versus Position Splint in Patients With Hip Fracture
|
N/A | |
Recruiting |
NCT05989217 -
Conservative Therapies in the Treatment of Temporomandibular Disorders
|
N/A | |
Not yet recruiting |
NCT05896410 -
3D-Printed Hand Orthosis Versus Thermoplastic Orthosis
|
N/A | |
Completed |
NCT05305586 -
Comparison of Two Types of Splints to Treat Dental Luxation Injuries
|
N/A | |
Completed |
NCT05731869 -
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
|
||
Completed |
NCT04523636 -
Evaluation of Splinting in Tetraplegia
|
N/A | |
Recruiting |
NCT05725941 -
Spiral Strapping for Improving Upper Limb Functions
|
N/A | |
Completed |
NCT06238440 -
Comparison of Different Treatment Approaches in Carpal Tunnel Syndrome
|
N/A | |
Completed |
NCT06131996 -
The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome
|
N/A | |
Completed |
NCT04796168 -
Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT05694078 -
Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
|
N/A | |
Completed |
NCT04934449 -
Occlusal Splints in the Treatment of Sleep Bruxism
|
N/A | |
Completed |
NCT04306796 -
3D Printed Made to Measure Splints for Hand Patients
|
N/A | |
Recruiting |
NCT04460521 -
The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome
|
Phase 4 | |
Recruiting |
NCT05908149 -
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
|
N/A | |
Completed |
NCT04257903 -
Different Treatment Modalities for Myofascial Pain
|