Sanders IV: Comparative Study of Fixation or Fusion of Calcaneal Fractures

• Sponsor: University of Calgary (Other)
• Overall Status: Completed
• CT.gov ID: NCT00679393
• Collaborator: Orthopaedic Trauma Association (Other), AO North America (Other)
• Enrollment: 26
• Locations: 4
• Arms: 2
• Duration (Months): 130
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Comminuted; Fracture Fixation, Internal	Procedure: Open reduction internal fixation; Procedure: Fusion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Fix Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)	Procedure: Open reduction internal fixation; Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
Other: Fuse Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).	Procedure: Fusion; Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Outcome Measures

Primary Outcome Measures

1. General Health Survey - SF-36 [6 months, 12 months, and 24 months]

Secondary Outcome Measures

1. Validated Visual Analogue Scale [6 months, 12 months, and 24 months]

2. Musculoskeletal Function Assessment [6 months, 12 months, and 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with Sanders IV displaced intra-articular calcaneal fracture

• males and females aged 16-59 inclusive

• ability to provide informed consent

• available for follow-up for at least 2 years after injury

Exclusion Criteria:

• medical contraindications to surgery

• previous calcaneal pathology (infection, tumor, etc)

• co-existent foot or ipsilateral lower limb injury

• open calcaneal fracture

• injury greater than 3 weeks old

• head injured patients

• inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system

• inability to comply with advice to diminish smoking after the injury

• metal allergy

• extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon

• any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
2	Halifax Infirmary, QEII Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 3A7
3	London Health Sciences Centre	London	Ontario	Canada
4	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• University of Calgary
• Orthopaedic Trauma Association
• AO North America

Investigators

• Principal Investigator: Richard E Buckley, MD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Buckley, Clinical Professor, Section of Orthopaedics, Department of Surgery, University of Calgary
• ClinicalTrials.gov Identifier: NCT00679393
• Other Study ID Numbers: 17526
• First Posted: May 16, 2008
• Last Update Posted: Feb 11, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Richard Buckley, Clinical Professor, Section of Orthopaedics, Department of Surgery, University of Calgary: Calcaneus; Intra-articular fracture; open reduction internal fixation; primary subtalar fusion
• Additional relevant MeSH terms: Fractures, Bone; Fractures, Comminuted; Intra-Articular Fractures

Study Results

No Results Posted as of Feb 11, 2015