Tibial Shaft FracturePhase 2NCT01190709
Study of Tibial Shaft Fracture Fixation: Intramedullary Nailing Comparing With Dynamic Compression Plate
A Phase 2 study testing Dynamic Compression Plate and Unreamed intramedullary nailing in people with Tibial Shaft Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tibial Shaft Fracture
- What is being tested?
- Dynamic Compression Plate and Unreamed intramedullary nailing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Mar 2009
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient with tibial shaft fracture
Who cannot join
- nothing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Surgical Methods for Treatment of Tibial Fractures
The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture
Read the detailed description
Tibial fracture is more common fracture. We aimed to compare unreamed intramedullary nailing (UTN) and dynamic compression plate (DCP) with regard to fracture healing and complications in patients with closed tibial shaft fractures.
- Conditions
- Tibial Shaft Fracture
- Being tested
- Dynamic Compression Plate, Unreamed intramedullary nailing
- Keywords
- Close Fracture, Tibia, Unreamed Intramedullary Nailing, Dynamic Compression Plate
- Medical subject headings
- Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Compression PlateProcedure or surgery
Also called DCP
we made a longitudinal incision 1 cm lateral to the tibial crest, expose the fracture, and retract the muscles laterally. After determining the length of plate, we used bending instruments to contour the plate to the anatomy then threaded plate holders used to position the plate on the bone. After that we placed the drill guide at the edge of the dynamic compression unit (DCU) portion of the plate hole without applying pressure and tightening of the cortex screws results in dynamic compression. We verified the screw position with a guide wire before insertion and then inserted the locking screw.
Unreamed intramedullary nailingProcedure or surgery
Also called DCP
we inserted the nail, without reaming, across the fracture site, with particular attention being paid to the prevention of over distraction and the achievement of cortical contact of the fracture ends. An upper diameter limit of 10 mm and a nail measuring at least 2 mm less than the diameter measured at the isthmus of the tibia on anteroposterior and lateral radiographs were stipulated.
| Study group | Role | What they receive |
|---|---|---|
| unreamed Intramedullary Nailing | Other | tibial fracture fixed with unreamed Intramedullary Nailing Receives: Procedure: Unreamed intramedullary nailing |
| Dynamic Compression Plate | Other | tibial fracture fixed with Dynamic Compression Plate Receives: Procedure: Dynamic Compression Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of fracture healing
identification of time of fracture healing in patients who underwent plate or nail methods
Measured: at 16 months post-operatively
Secondary outcomes (3)
malunion
identification of rate of malunion in two surgical groups
Measured: at 16 months post-operatively
nonunion
identification of rate of nonunion in two surgical groups
Measured: at 16 months post-operatively
infection
identification of rate of infection in two surgical groups
Measured: at 16 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Shaft FractureStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190709
- Sponsor's protocol ID
- ASD-1213-6
- Status last verified
- Oct 2008
- First submitted
- 27 Aug 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Methods for Treatment of Tibial Fractures
- ClinicalTrials.gov ID
- NCT01190709
- Acronym / sponsor ID
- ASD-1213-6
- Conditions
- Tibial Shaft Fracture
- Keywords
- Close Fracture, Tibia, Unreamed Intramedullary Nailing, Dynamic Compression Plate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Aug 2010 (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 determine which surgical approach is better for treatment of tibial shaft fracture
Detailed description
Tibial fracture is more common fracture. We aimed to compare unreamed intramedullary nailing (UTN) and dynamic compression plate (DCP) with regard to fracture healing and complications in patients with closed tibial shaft fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unreamed Intramedullary Nailing | Other | Procedure: Unreamed intramedullary nailingtibial fracture fixed with unreamed Intramedullary Nailing |
| Dynamic Compression Plate | Other | Procedure: Dynamic Compression Platetibial fracture fixed with Dynamic Compression Plate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with tibial shaft fracture
Key exclusion criteria (1 listed)
- nothing
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 |
|---|---|---|
| Dynamic Compression PlateAlso: DCPwe made a longitudinal incision 1 cm lateral to the tibial crest, expose the fracture, and retract the muscles laterally. After determining the length of plate, we used bending instruments to contour the plate to the anatomy then threaded plate holders used to position the plate on the bone. After that we placed the drill guide at the edge of the dynamic compression unit (DCU) portion of the plate hole without applying pressure and tightening of the cortex screws results in dynamic compression. We verified the screw position with a guide wire before insertion and then inserted the locking screw. | Procedure or surgery | Dynamic Compression Plate |
| Unreamed intramedullary nailingAlso: DCPwe inserted the nail, without reaming, across the fracture site, with particular attention being paid to the prevention of over distraction and the achievement of cortical contact of the fracture ends. An upper diameter limit of 10 mm and a nail measuring at least 2 mm less than the diameter measured at the isthmus of the tibia on anteroposterior and lateral radiographs were stipulated. | Procedure or surgery | unreamed Intramedullary Nailing |
Primary outcome
time of fracture healing
Time frame: at 16 months post-operatively
identification of time of fracture healing in patients who underwent plate or nail methods
3 secondary outcomes
malunion
Time frame: at 16 months post-operatively
nonunion
Time frame: at 16 months post-operatively
infection
Time frame: at 16 months post-operatively
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 30 Aug 2010.
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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.
hamidreza shemshaki, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dynamic Compression Plate and Unreamed intramedullary nailing in people with Tibial Shaft Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 30 Aug 2010. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
time of fracture healing (time frame: at 16 months post-operatively). 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 30 Aug 2010.