Closed Transverse Fracture of Shaft of TibiaNCT03042533
Union Rate of Transverse Tibia Fracture
A study testing Conventional Compression, Standard Backslapping and Dynamic Locking with Backslapping in people with Closed Transverse Fracture of Shaft of Tibia, run by University of Washington at 1 site in United States.
Trial summary
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Closed Transverse Fracture of Shaft of Tibia
- What is being tested?
- Conventional Compression, Standard Backslapping and Dynamic Locking with Backslapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 29 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Closed Tibia Shaft Fracture Treated with an IMN
Who cannot join
- Unable to consent due to language
- Unlikely to follow-up for one year
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
- Being tested
- Conventional Compression, Standard Backslapping, Dynamic Locking with Backslapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional CompressionDevice
Method of Nail fitting
Standard BackslappingDevice
Method of Nail fitting
Dynamic Locking with BackslappingDevice
Method of Nail fitting
| Study group | Role | What they receive |
|---|---|---|
| Conventional Compression | Active comparator | Nail will be seated using conventional compression technique Receives: Device: Conventional Compression |
| Standard Backslapping | Active comparator | Nail will be seated using standard backslapping technique Receives: Device: Standard Backslapping |
| Dynamic Locking with Backslapping | Active comparator | Nail will be seated using backslapping with dynamic locking Receives: Device: Dynamic Locking with Backslapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of Tibia Fracture by Radiographic Exam
Healing of Tibia Fracture by radiographic exam
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Closed Transverse Fracture of Shaft of TibiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Sagi, University of Washington
- Investigators
- Claude Sagi, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042533
- Sponsor's protocol ID
- STUDY00001680
- Status last verified
- May 2024
- First submitted
- 27 Jan 2017
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently there is no plan
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking
- ClinicalTrials.gov ID
- NCT03042533
- Acronym / sponsor ID
- STUDY00001680
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Compression | Active comparator | Device: Conventional CompressionNail will be seated using conventional compression technique |
| Standard Backslapping | Active comparator | Device: Standard BackslappingNail will be seated using standard backslapping technique |
| Dynamic Locking with Backslapping | Active comparator | Device: Dynamic Locking with BackslappingNail will be seated using backslapping with dynamic locking |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Closed Tibia Shaft Fracture Treated with an IMN
Key exclusion criteria (2 listed)
- Unable to consent due to language
- Unlikely to follow-up for one year
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 |
|---|---|---|
| Conventional CompressionMethod of Nail fitting | Device | Conventional Compression |
| Standard BackslappingMethod of Nail fitting | Device | Standard Backslapping |
| Dynamic Locking with BackslappingMethod of Nail fitting | Device | Dynamic Locking with Backslapping |
Primary outcome
Healing of Tibia Fracture by Radiographic Exam
Time frame: One Year
Healing of Tibia Fracture by radiographic exam
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Currently there is no plan
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.
Claude Sagi principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Compression, Standard Backslapping and Dynamic Locking with Backslapping in people with Closed Transverse Fracture of Shaft of Tibia, run by University of Washington 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 May 2024. 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?
Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healing of Tibia Fracture by Radiographic Exam (time frame: One Year). 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 3 May 2024.