Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial

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.

Conditions

• Metatarsal Fracture
• Treatment

Interventions

PROCEDURE

Protected weightbearing in a hard-soled shoe

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

PROCEDURE

Protected weightbearing in a short leg walking cast

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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital

  lead OTHER

Principal Investigators

• Hyong Nyun Kim, MD, PhD · Kangnam Sacred Heart Hospital, Hallym University College of Medicine

• Hyong Nyun Kim, MD, PhD · Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2016-01-31

Completion

2017-01-31

Countries

• South Korea

Study Locations