Treatment Clinical Trial
Official title:
Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial
Fifth metatarsal avulsion fractures are common and can usually be treated conservatively.
Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast
walking boot, or below-knee walking cast have been successful. Several papers reported that
early rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in
early return to activities. However, early motion of the ankle joint may have the risk of
displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole
shoe for protected weightbearing and allowing motion of the ankle joint had successful
results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth
metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully
and that the results were similar between the two. However, this was not a randomized
controlled trial.
Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used
for the treatment. However, we decided to compare results of hard-soled shoe and short leg
walking cast for the treatment of a fifth metatarsal avulsion fracture.
We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a
fifth metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe
is not inferior to protected weightbearing in a short leg walking cast but is superior to
short leg walking cast with respect to time to return to normal daily life and patient's
satisfaction.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | January 2017 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age between 18 and 65 years - fifth metatarsal avulsion fracture Exclusion Criteria: - open fractures - pathologic fractures - a fifth metatarsal avulsion fracture combined with other lower extremity injuries such as Lisfranc injury - patients with diabetes or neuroarthropathy - patients with obesity (BMI >30, weight >100 kg) - any other conditions that are expected to prevent the patients from following the study protocol |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sanbon Hospital, Wonkwang University College of Medicine | Gunpo | Gyeongi |
Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam | Gyeongi |
Korea, Republic of | Kangnam Sacred Heart Hospital, Hallym University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hallym University Kangnam Sacred Heart Hospital |
Korea, Republic of,
Clapper MF, O'Brien TJ, Lyons PM. Fractures of the fifth metatarsal. Analysis of a fracture registry. Clin Orthop Relat Res. 1995 Jun;(315):238-41. Review. — View Citation
Gray AC, Rooney BP, Ingram R. A prospective comparison of two treatment options for tuberosity fractures of the proximal fifth metatarsal. Foot (Edinb). 2008 Sep;18(3):156-8. doi: 10.1016/j.foot.2008.02.002. Epub 2008 May 19. — View Citation
Heineck J, Wolz M, Haupt C, Rammelt S, Schneiders W. Fifth metatarsal avulsion fracture: a rational basis for postoperative treatment. Arch Orthop Trauma Surg. 2009 Aug;129(8):1089-92. doi: 10.1007/s00402-008-0756-x. Epub 2008 Sep 26. — View Citation
Shahid MK, Punwar S, Boulind C, Bannister G. Aircast walking boot and below-knee walking cast for avulsion fractures of the base of the fifth metatarsal: a comparative cohort study. Foot Ankle Int. 2013 Jan;34(1):75-9. doi: 10.1177/1071100712460197. — View Citation
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. — View Citation
Vorlat P, Achtergael W, Haentjens P. Predictors of outcome of non-displaced fractures of the base of the fifth metatarsal. Int Orthop. 2007 Feb;31(1):5-10. Epub 2006 May 23. — View Citation
Wiener BD, Linder JF, Giattini JF. Treatment of fractures of the fifth metatarsal: a prospective study. Foot Ankle Int. 1997 May;18(5):267-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 100mm visual analogue scale (VAS) | The 100mm VAS is widely used self assessment tool for evaluating pain after fracture. | 6 months after a fifth metatarsal avulsion fracture | No |
Secondary | Time to return to preinjury activity | upto 6 months | No | |
Secondary | patients' subjective satisfactions | 3, 5, 8, 12 weeks and 6 months after injury | No |
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