Fractures, ComminutedSanders IVNCT00679393
Comparative Study of Fixation or Fusion of Calcaneal Fractures
A study testing Open reduction internal fixation and Fusion in people with Fractures, Comminuted and Fracture Fixation, Internal, run by University of Calgary at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 59 years
- Conditions the study is for
- Fractures, Comminuted, Fracture Fixation, Internal
- What is being tested?
- Open reduction internal fixation and Fusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesCanada
- Study dates
- Feb 2004to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Halifax Infirmary, QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
London Health Sciences Centre
London, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
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
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.
- Conditions
- Fractures, Comminuted, Fracture Fixation, Internal
- Being tested
- Open reduction internal fixation, Fusion
- Keywords
- Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion
- Medical subject headings
- Fractures, Comminuted, Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction internal fixationProcedure or surgery
Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
FusionProcedure or surgery
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)
| Study group | Role | What they receive |
|---|---|---|
| Fix | Other | Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV) Receives: Procedure: Open reduction internal fixation |
| Fuse | Other | Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV). Receives: Procedure: Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Health Survey - SF-36
Measured: 6 months, 12 months, and 24 months
Secondary outcomes (2)
Validated Visual Analogue Scale
Measured: 6 months, 12 months, and 24 months
Musculoskeletal Function Assessment
Measured: 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, ComminutedStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, AO North America
- Responsible party
- Principal investigator, Richard Buckley, University of Calgary
- Investigators
- Richard E Buckley, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679393
- Sponsor's protocol ID
- 17526
- Acronym
- Sanders IV
- Status last verified
- Feb 2015
- First submitted
- 14 May 2008
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00679393
- Acronym / sponsor ID
- Sanders IV / 17526
- Conditions
- Fractures, Comminuted, Fracture Fixation, Internal
- Keywords
- Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, AO North America
- Study start
- Feb 2004
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fix | Other | Procedure: Open reduction internal fixationOpen reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV) |
| Fuse | Other | Procedure: FusionPrimary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV). |
Who may qualify
- Ages
- 16 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction internal fixationOpen reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV). | Procedure or surgery | Fix |
| FusionPrimary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV) | Procedure or surgery | Fuse |
Primary outcome
General Health Survey - SF-36
Time frame: 6 months, 12 months, and 24 months
2 secondary outcomes
Validated Visual Analogue Scale
Time frame: 6 months, 12 months, and 24 months
Musculoskeletal Function Assessment
Time frame: 6 months, 12 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Buckley, MD principal investigator
University of Calgary
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction internal fixation and Fusion in people with Fractures, Comminuted and Fracture Fixation, Internal, run by University of Calgary at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Survey - SF-36 (time frame: 6 months, 12 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.