Operative Versus Non Operative Treatment for Unstable Ankle Fractures

NCT00336752 | Completed

• 2 other identifiers: R-03-113HSREB09641
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare functional outcomes and recovery following surgical and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary objectives are to compare the re-operation rate, time to union and complications between the two treatment groups. The primary research questions:

1. 1.Does surgery provide a better functional outcome compared to non operative treatment of undisplaced, unstable fractures?
2. 2.Do patients with these fractures return to activities faster after operative or non operative treatment?
3. 3.Are complications more common with operative or non operative care?

Conditions

Ankle Injuries

Keywords

undisplaced ,unstable wEBER B ankle fractures; operative intervention; non operative intervention

Outcome Measures

Primary Outcomes (1)

• Primary outcome: comparison of physical functioning score on SF36

  enrolment, 6 weeks, 3,6 12 months

Secondary Outcomes (1)

• Secondary objectives are to compare the re-operation rate between operative and non-operative treatment and to compare the time to union, rates of nonunion and complications such as infection between the two groups.

  enrolment, 6 weeks, 3,6,12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Non operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention

Procedure: non operative treatment

2

ACTIVE COMPARATOR

Operative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones.

Procedure: operative treatment of ankle fractures

Interventions

non operative treatment PROCEDURE

non operative treatment -casting for 6 weeks

1

operative treatment of ankle fractures PROCEDURE

operative treatment of ankle fractures

2

Eligibility Criteria

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

You may qualify if:

• Skeletally mature male or female \< 65 years of age
• Unstable ankle on stress exam: medial clear space ³ 5 mm: no Mortise shift on static radiographs
• Unilateral Weber B fibular fractures
• Closed fracture
• Provision of informed consent -

You may not qualify if:

• Fractures not amenable to surgical treatment
• Pathologic fracture
• Associated injuries to the foot, ankle, tibia, or knee
• Associated medial malleolus fracture
• Surgical delay of \>2 weeks from time of injury
• Previous fracture or retained hardware in the affected limb
• Associated neurovascular injury or deficit in the affected limb
• Systemic diseases including diabetes, multiple sclerosis, Parkinson's disease, and other disorders which might affect peripheral sensorimotor function -

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

LOndon Health Sciences cEntre- Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• DR. David Sanders, M.D., FRCSC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 14, 2006
• Study Start: June 1, 2003
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)