NCT02050698

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

January 29, 2014

Last Update Submit

October 11, 2015

Conditions

Metatarsal FractureTreatment

Keywords

fift metatarsal avulsion fracturehard-soled shoeshort leg walking castprotected weightbearing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Time to return to preinjury activity

    upto 6 months

  • patients' subjective satisfactions

    3, 5, 8, 12 weeks and 6 months after injury

Study Arms (2)

short leg walking cast

ACTIVE COMPARATOR

After 1 weeks of immobilization in a short leg posterior splint, patient is allowed protected weightbearing in a short leg walking cast

Procedure: Protected weightbearing in a short leg walking cast

hard-soled shoe

EXPERIMENTAL

After 1 weeks of immobilization in a short leg posterior splint, patient is allowed tolerable weightbearing in a hard-soled shoe

Procedure: Protected weightbearing in a hard-soled shoe

Interventions

Protected weightbearing in a hard-soled shoePROCEDURE

Patients allocated to experiment group are allowed tolerable weightbearing in a hard-soled shoe after one week of immobilization in a posterior splint

hard-soled shoe
Protected weightbearing in a short leg walking castPROCEDURE

Patients allocated to control group are allowed tolerable weightbearing in a short leg walking cast after one week of immobilization in a posterior splint

short leg walking cast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 65 years
  • fifth metatarsal avulsion fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanbon Hospital, Wonkwang University College of Medicine

Gunpo, Gyeongi, 435-040, South Korea

RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam, Gyeongi, 463-712, South Korea

RECRUITING

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, 150-950, South Korea

RECRUITING

Related Publications (7)

  • 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. doi: 10.1016/s0196-0644(96)70238-x.

    PMID: 8604867BACKGROUND

  • 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.

    PMID: 7634674BACKGROUND

  • 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.

    PMID: 20307430BACKGROUND

  • 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.

    PMID: 18818936BACKGROUND

  • 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.

    PMID: 23386764BACKGROUND

  • 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. doi: 10.1007/s00264-006-0116-9. Epub 2006 May 23.

    PMID: 16721621BACKGROUND

  • 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. doi: 10.1177/107110079701800504.

    PMID: 9167925BACKGROUND

Study Officials

  • Hyong Nyun Kim, MD, PhD

    Kangnam Sacred Heart Hospital, Hallym University College of Medicine

    STUDY CHAIR

  • Hyong Nyun Kim, MD, PhD

    Kangnam Sacred Heart Hospital, Hallym University College of Medicine

    STUDY DIRECTOR

Central Study Contacts

Hyong Nyun Kim, MD, PhD

CONTACT

+82-2-829-5165hyongnyun@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

KR(3)