Calcaneus FracturesCALCANEUSNCT00582686
Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft
A study testing ORIF of Calcaneus with bone grafting and ORIF of Calcaneus without bone grafting in people with Calcaneus Fractures, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Calcaneus Fractures
- What is being tested?
- ORIF of Calcaneus with bone grafting and ORIF of Calcaneus without bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Mar 2008
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intra-articular calcaneus fractures requiring open reduction and internal fixation
- Adult patient (19 years or older)
- Mental capacity to comply with post-operative regimen, evaluation and data collection
Who cannot join
- non-operative fractures for primary or secondary reasons
- prior surgery to the hindfoot of the involved lower extremity
- inability to comply with post-operative regimen, evaluation and data collection
- inability or unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, 35294
About this study
Official title: Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting
Read the detailed description
This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.
- Conditions
- Calcaneus Fractures
- Being tested
- ORIF of Calcaneus with bone grafting, ORIF of Calcaneus without bone grafting
- Keywords
- Calcaneus Fractures, Iliac Crest Bone Grafting, Open Reduction & Internal Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF of Calcaneus with bone graftingProcedure or surgery
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting
ORIF of Calcaneus without bone graftingProcedure or surgery
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)
| Study group | Role | What they receive |
|---|---|---|
| ORIF with Bone Grafting | Active comparator | This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group A will be made up of patients that undergo ORIF and Tricortical iliac crest bone grafting. Receives: Procedure: ORIF of Calcaneus with bone grafting |
| ORIF without Bone Grafting | Active comparator | This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting Receives: Procedure: ORIF of Calcaneus without bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union and healing of Calcaneus Fracture
Measured: 3 month to 12 month healing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMay 2000
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FracturesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rena L Stewart, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582686
- Sponsor's protocol ID
- F990923008
- Acronym
- CALCANEUS
- Status last verified
- Sep 2013
- First submitted
- 20 Dec 2007
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
- ClinicalTrials.gov ID
- NCT00582686
- Acronym / sponsor ID
- CALCANEUS / F990923008
- Conditions
- Calcaneus Fractures
- Keywords
- Calcaneus Fractures, Iliac Crest Bone Grafting, Open Reduction & Internal Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Dec 2007 (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.
The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting
Detailed description
This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORIF with Bone Grafting | Active comparator | Procedure: ORIF of Calcaneus with bone graftingThis study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group A will be made up of patients that undergo ORIF and Tricortical iliac crest bone grafting. |
| ORIF without Bone Grafting | Active comparator | Procedure: ORIF of Calcaneus without bone graftingThis study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- intra-articular calcaneus fractures requiring open reduction and internal fixation
- Adult patient (19 years or older)
- Mental capacity to comply with post-operative regimen, evaluation and data collection
Key exclusion criteria (4 listed)
- non-operative fractures for primary or secondary reasons
- prior surgery to the hindfoot of the involved lower extremity
- inability to comply with post-operative regimen, evaluation and data collection
- inability or unwillingness to give informed consent
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 |
|---|---|---|
| ORIF of Calcaneus with bone graftingThe calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting | Procedure or surgery | ORIF with Bone Grafting |
| ORIF of Calcaneus without bone graftingThe calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting) | Procedure or surgery | ORIF without Bone Grafting |
Primary outcome
Union and healing of Calcaneus Fracture
Time frame: 3 month to 12 month healing period
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 1 Oct 2013.
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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.
Rena L Stewart, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF of Calcaneus with bone grafting and ORIF of Calcaneus without bone grafting in people with Calcaneus Fractures, run by University of Alabama at Birmingham at 1 site in United States.
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 3 inclusion and 4 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Union and healing of Calcaneus Fracture (time frame: 3 month to 12 month healing period). 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 1 Oct 2013.