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

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02050698
• Other study ID #: IRB2014-OS01
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2014
• Last updated: October 11, 2015
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: October 2015
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: Hyong Nyun Kim, MD, PhD
• Phone: +82-2-829-5165
• Email: hyongnyun[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers. The primary outcome measure is the 100mm VAS assessed on 6 months after a fifth metatarsal avulsion fracture. 100mm VAS was compared between the experimental group (hard-soled shoe) and the control group (short leg walking cast) on 6 months follow-up examination. The 100mm VAS is widely used self assessment tool for evaluating pain after fracture. The secondary objectives were to determine whether hard-soled shoe was superior to short leg walking cast with respect to time until return to normal daily life and patient's satisfaction.

The sample size was determined using methods appropriate for noninferiority trials, assuming 90% power and a significance level of 0.05. We performed a pilot study on 18 patients and assessed 100mm VAS on 6 months. Pooled standard deviation was 16.6. To find out whether the hard-soled shoe is not inferior to short leg walking cast for a fifth metatarsal avulsion fracture, 74 patients were required to have 90% power that the lower limit of an one-sided 95% confidence interval for the difference between two treatments will be above the noninferiority margin of -10. We assumed the drop-out rate to be 20%. Adding this number, 96 patients were required for the study.

Determination of the noninferiority margin was based on clinical significance. Todd et al. reported on a study of 48 patients that the minimum clinically significant difference of 100mm VAS was 13mm and that differences of less than this amount, even if statistically significant, are unlikely to be of clinical significance. We decided that the noninferiority margin at 10 mm difference which is less than this amount will be adequate to prove noninferiority of the experiment group (hard-soled shoe) over the control group (short leg walking cast).

After 1 weeks of immobilization in a short leg posterior splint, patients are randomized to experiment group (hard-soled shoe) and control group (short leg walking cast). Randomization was stratified by the study centers. Block randomization were used and the investigators were blinded to the block sizes being used to ensure allocation concealment. Delayed union was defined as a lack of bridging callus on 3 of 5 cortices at 12 weeks. Nonunion was defined as lack of cortical bridging or a clearly visible fracture line, at 14 weeks post injury.

If a subject had discontinued prior to completion of 6 months, the last observation was carried forward for the intent-to-treat analysis. Subjects who crossed over to the other treatment arm, for an example, patients in experiment group(hard-soled shoe) who changed to short leg walking cast or in control group (short leg walking cast) who changed to hard-soled shoe, were analyzed according to their initial group allocation for the intent-to-treat analysis. Additionally, an as-treated (per-protocal) analysis was also conducted on patients who completed the 6 months follow-up with the protocol assigned.

Although previous studied have not documented an increase risk of reduction loss with protected weightbearing in a hard-soled shoe protocol, a safety rule was put in place to assure patients, clinicians, and the health research ethics board that the safety of our patients was a priority. Reduction loss was not a primary outcome, but it was monitored carefully regardless of published evidence. A safety rule established a priori eliminated any dissent among the research team and participating surgeons about stopping the study in the event of an apparent adverse outcome related to protected weightbearing in a hard-soled shoe. If a difference of greater than three spontaneous reduction loss occurred between the groups, the intervention would be halted. A reduction loss or metal failure was defined as one that occurred without patient instigation of inappropriate activity. The reduction loss was to be monitored by study personnel not involved in the outcome assessment.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Metatarsal Fracture
• Treatment

Intervention

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
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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

Outcome

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