Combined Randomised and Observational Study of Surgery for Type B Ankle Fracture Treatment

NCT03083028 | Unknown

• 1 other identifier: CROSSBAT 5Y
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Ankle Fracture

Outcome Measures

Primary Outcomes (2)

• American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire

  American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire

  5 years

• PCS of Short Form (SF)-12v2

  SF-12 version 2 Health Survey

  5 years

Secondary Outcomes (2)

• Complications

  5 years

• MCS of Short Form (SF)-12v2

  5 years

Study Arms (2)

Non Operative

ACTIVE COMPARATOR

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.

Procedure: Non Operative

Operative

ACTIVE COMPARATOR

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: Open reduction internal fixation of the ankl

Interventions

Non Operative PROCEDURE

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.

Non Operative

Open reduction internal fixation of the ankl PROCEDURE

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.

Operative

Eligibility Criteria

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

You may qualify if:

• \- Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture Patients aged between 18 and 65 inclusive. No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle.
• Closed injury No concurrent fractures/dislocations Mobilising unaided/independently pre-injury Willingness to be followed up for 12 months Able to provide informed written consent

You may not qualify if:

• \- Medically fit for general anaesthesia/surgery Dislocation on presentation Skeletally immature patients Previous trauma or surgery to the affected ankle Pregnancy Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation Non-English speaking

Sponsors & Collaborators

• The University of New South Wales: lead

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Rajat Mittal, BSc (Med), MBBS, MMed, MS

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor were masked to the treatment allocation of participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial with an Observational Cohort

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: August 1, 2010
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 17, 2017

Record last verified: 2017-03