Comparative Study of Fixation or Fusion of Calcaneal Fractures (Sanders IV)
This study is currently recruiting participants.
Verified May 2010 by University of Calgary
Sponsor:
University of Calgary
Collaborators:
Orthopaedic Trauma Association
AO North America
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00679393
First received: May 14, 2008
Last updated: May 10, 2010
Last verified: May 2010
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Purpose
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 | Intervention |
|---|---|
|
Fractures, Comminuted Fracture Fixation, Internal |
Procedure: Open reduction internal fixation Procedure: Fusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- General Health Survey - SF-36 [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Validated Visual Analogue Scale [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
- Musculoskeletal Function Assessment [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
|
Fuse
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
|
Procedure: Fusion
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)
|
Eligibility| Ages Eligible for Study: | 16 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679393
Contacts
| Contact: Kimberly Carcary, MSc, CCRP | 403-944-2932 | kdcarcar@ucalgary.ca |
Locations
| Canada, Alberta | |
| Foothills Medical Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Principal Investigator: Richard E Buckley, MD | |
| Canada, Nova Scotia | |
| Halifax Infirmary, QEII Health Sciences Center | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: Ross Leighton, MD | |
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Principal Investigator: David Sanders, MD | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: David Stephen, MD | |
Sponsors and Collaborators
University of Calgary
Orthopaedic Trauma Association
AO North America
Investigators
| Principal Investigator: | Richard E Buckley, MD | University of Calgary |
More Information
No publications provided
| Responsible Party: | Dr. Richard E. Buckley, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00679393 History of Changes |
| Other Study ID Numbers: | 17526 |
| Study First Received: | May 14, 2008 |
| Last Updated: | May 10, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
Calcaneus Intra-articular fracture open reduction internal fixation primary subtalar fusion |
Additional relevant MeSH terms:
|
Fractures, Bone Intra-Articular Fractures Fractures, Comminuted Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013