Tibial Shaft Fractures in ChildrenNCT01238523
Study of Tibial Shaft Fractures in Children
A study testing Long leg cast in full extension and Long leg cast with 45 degrees of flexion in people with Tibial Shaft Fractures in Children, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Tibial Shaft Fractures in Children
- What is being tested?
- Long leg cast in full extension and Long leg cast with 45 degrees of flexion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2010
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 4 and 14 years of age (open physis)
- Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
- All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern
Who cannot join
- Fractures with greater than 2 cm of initial shortening
- Open fractures
- Patients that have other orthopaedic medical issues such as hemophilia
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Orthopaedic Hospital
Los Angeles, California, 90007
About this study
Official title: Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).
The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study
- Conditions
- Tibial Shaft Fractures in Children
- Being tested
- Long leg cast in full extension, Long leg cast with 45 degrees of flexion
- Keywords
- tibia, shaft, fracture, children
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long leg cast in full extensionProcedure or surgery
Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity
Long leg cast with 45 degrees of flexionProcedure or surgery
Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
| Study group | Role | What they receive |
|---|---|---|
| Long leg cast in full extension | Experimental | Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity Receives: Procedure: Long leg cast in full extension |
| Long leg cast with 45 degrees of flexion | Experimental | Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity Receives: Procedure: Long leg cast with 45 degrees of flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Activities Scale for Kids - Performance (ASK-P)
The Activities Scale for Kids (ASK) is a 30 item child self-report musculoskeletal outcome measure that focuses on the child's physical disability, and is scored with a summary score with no sub-scales. The performance format ASK-P will be used in this study. The scoring system is from 0-100 with 100 being the best possible score.
Measured: May 2007 - May 2010
Secondary outcomes (1)
Time to Healing
Radiographic union will be defined as the presence of callus bridging of 3 out of 4 cortices as seen on anterior posterior and lateral radiographs.
Measured: May 2007 - May 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial Shaft Fractures in ChildrenStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles Orthopaedic Hospital
- Responsible party
- Principal investigator, Mauricio Silva, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238523
- Sponsor's protocol ID
- OH-001
- Status last verified
- May 2010
- First submitted
- 9 Nov 2010
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silva M, Eagan MJ, Wong MA, Dichter DH, Ebramzadeh E, Zionts LE. A comparison of two approaches for the closed treatment of low-energy tibial fractures in children. J Bone Joint Surg Am. 2012 Oct 17;94(20):1853-60. doi: 10.2106/JBJS.J.01728.
PubMed 23079877
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
- ClinicalTrials.gov ID
- NCT01238523
- Acronym / sponsor ID
- OH-001
- Conditions
- Tibial Shaft Fractures in Children
- Keywords
- tibia, shaft, fracture, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Los Angeles Orthopaedic Hospital
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 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.
Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5).
The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long leg cast in full extension | Experimental | Procedure: Long leg cast in full extensionLong leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity |
| Long leg cast with 45 degrees of flexion | Experimental | Procedure: Long leg cast with 45 degrees of flexionLong leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients between 4 and 14 years of age (open physis)
- Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury
- All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern
Key exclusion criteria (3 listed)
- Fractures with greater than 2 cm of initial shortening
- Open fractures
- Patients that have other orthopaedic medical issues such as hemophilia
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 |
|---|---|---|
| Long leg cast in full extensionLong leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity | Procedure or surgery | Long leg cast in full extension |
| Long leg cast with 45 degrees of flexionLong leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity | Procedure or surgery | Long leg cast with 45 degrees of flexion |
Primary outcome
The Activities Scale for Kids - Performance (ASK-P)
Time frame: May 2007 - May 2010
The Activities Scale for Kids (ASK) is a 30 item child self-report musculoskeletal outcome measure that focuses on the child's physical disability, and is scored with a summary score with no sub-scales. The performance format ASK-P will be used in this study. The scoring system is from 0-100 with 100 being the best possible score.
1 secondary outcome
Time to Healing
Time frame: May 2007 - May 2010
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 17 Aug 2017.
- Results publication: PubMed 23079877Silva M, Eagan MJ, Wong MA, Dichter DH, Ebramzadeh E, Zionts LE. A comparison of two approaches for the closed treatment of low-energy tibial fractures in children. J Bone Joint Surg Am. 2012 Oct 17;94(20):1853-60. doi: 10.2106/JBJS.J.01728.
Related trials for Tibial Shaft Fractures in Children
Not yet recruiting
Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures
Fracture of Tibia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long leg cast in full extension and Long leg cast with 45 degrees of flexion in people with Tibial Shaft Fractures in Children, run by University of California, Los Angeles 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 3 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 17 Aug 2017. 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?
The Activities Scale for Kids - Performance (ASK-P) (time frame: May 2007 - May 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238523, which also lists 1 linked publication.
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 17 Aug 2017.