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Combined Randomised and Observational Study of Type B Ankle Fracture Treatment

NCT01134094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-06-24

No results posted yet for this study

Summary

This study will determine whether operative management confers improved short and long-term outcomes for patients with isolated AO type 44-B1 distal fibula fractures when compared with non-operative management.

Conditions

  • Ankle Fractures

Interventions

PROCEDURE

Open reduction internal fixation of the ankle

The specific procedure for each patient managed operatively, both in the observational study and the RCT, will be determined by the operating surgeon. Any adverse intra-operative or post-operative event will be recorded. This includes but is not limited to death, infection and neurovascular injury. Post operatively, all patients will be NWB (non weight bearing) and placed in a POP (plaster of paris) below knee cast or walking boot. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. The treating surgeon will review the patients after 10-14 days for a wound review, removal of sutures and change of cast to a fibreglass cast or walking boot (cam walker). The patient will be WBAT (weight bearing as tolerated) for a further 4 weeks.

PROCEDURE

Non Operative

Patients who are treated non-operatively will be treated with a walking boot and allowed WBAT. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. All patients will be reviewed between 7 and 14 days post injury with repeat x-rays by the treating surgeon.

Sponsors & Collaborators

  • CROSSBAT Investigators

    collaborator UNKNOWN

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Ian Harris, MBBS, PhD, FRACS · University of New South Wales, Whitlam Orthopaedic Research Centre

  • Rajat Mittal, Bsc (Med) MBBS · University of New South Wales, Whitlam Orthopaedic Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134094 on ClinicalTrials.gov