An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone

NCT01592604 | Completed DMC

• 1 other identifier: STH 15761
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common fractures in the foot, frequently treated in fracture clinics and involving significant resources. At present methods of treatment and follow up vary widely from no active treatment to surgery, depending entirely on a treating doctor preference. There is no agreement on simple, safe and reliable method of treatment. The investigators believe that vast majority of these injuries heal well on its own without any specific treatment. By comparing two most commonly used treatments the investigators aim to establish one simple, safe and reliable mode of treatments. The investigators are going to evaluate functional results of these two treatments in a short and longer time prospective, by using the best available scientific tools. The investigators believe that results of the investigators study will eventually lead to change of practise and more efficient NHS care for these patients. It will reduce unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a long prospective.

Conditions

Closed Fracture of Base of Fifth Metatarsal Bone

Keywords

fracture; fifth metatarsal; functioanl outcome

Outcome Measures

Primary Outcomes (1)

• Validated Visual analague scale for foot and ankle (VAS FA) score

  To evaluate functional outcome 6 months post treatment

  6 months post treatment

Secondary Outcomes (1)

• Euroqol 5D

  baseline, 4 weeks, 3 months, 6 months post treatment

Study Arms (2)

Treatment A

EXPERIMENTAL

Patients receive supportive compressive bandage for 4 weeks

Device: Compressive bandage

Treatment B

EXPERIMENTAL

Below knee walking plaster cast for 4 weeks

Device: Below knee walking cast

Interventions

Compressive bandage DEVICE

Compressive below knee bandage for 4 weeks in group A

Treatment A

Below knee walking cast DEVICE

Below knee walking cast for 4 weeks

Treatment B

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (older than 15 years of age) with an acute closed isolated type I avulsion fractures of the base of the fifth metatarsal bone, (within 7 days of the injury)

You may not qualify if:

• Diabetes, Inflammatory arthritis, previous same foot tarso-metatarsal fractures, previous same foot surgery, more than 7 days since the injury.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Northern General Hospital

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pavel - Akimau, MBChB

  Sheffield Teaching Hopsitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: May 7, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

GB (1)