Pediatric Femur FractureNCT06569199
Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
A study testing Functional Bracing and Hip Spica Cast in people with Pediatric Femur Fracture, run by University of Calgary at 1 site in Canada.
Trial summary
Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting. However, recent studies suggest that functional bracing may offer clinical and financial benefits, yet there's a lack of prospective trials comparing these two treatment methods. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Pediatric Femur Fracture
- What is being tested?
- Functional Bracing and Hip Spica Cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6mo-5 years
- Isolated closed diaphyseal femur fracture
- Parent or caregiver 18 years of age or older who are cognitively able to complete the parent/caregiver satisfaction survey.
Who cannot join
- Patients <6 months or >5 years of age
- Underlying neuromuscular disorders
- Open diaphyseal femur fracture
- Polytrauma
- Medical comorbidities impacting fracture healing
- <6 week follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Alberta Children's Hospital
Calgary, Alberta, T3C 1N9
Ben Wajda, MD, 4034651996, benjamin.wajda@ucalgary.ca
About this study
Official title: Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures: A Randomized Prospective Study and Cost-effectiveness Analysis
Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting. However, recent studies suggest that functional bracing may offer clinical and financial benefits, yet there's a lack of prospective trials comparing these two treatment methods. This single-center randomized-control trial aims to assess subjective and objective clinical outcomes as well as financial aspects of functional bracing versus spica casting. Functional bracing, proposed as a potentially superior alternative, may address caregiver challenges and reduce costs by avoiding operating room time and hospital admissions. The study will evaluate fracture reduction, time to union, functional outcomes, and caregiver satisfaction. Additionally, a comprehensive cost-effectiveness analysis will be conducted. Ultimately, this research aims to inform clinical decision-making regarding the optimal management of pediatric femur fractures, considering both clinical effectiveness and economic implications.
Read the detailed description
Pediatric diaphyseal femur fractures are a common orthopedic injury in children, with about one-third occurring in patients under the age of five. These fractures require effective management to promote optimal healing and functional recovery. In the 6-month to 5-year-old age group, diaphyseal femur fractures have traditionally been treated with a hip spica cast. Application of a hip spica cast typically occurs in the operating room (OR) under general anesthesia given that patients must undergo prolonged sedation for cast application. Caring for a child with a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility. This makes routine activities such as daily hygiene, toileting and skin surveillance difficult for caregivers. An ecological study performed by Kocher et al. found that spica casting places a greater burden on family functioning than medical treatment in children with serious chronic medical conditions including diabetes, renal failure, and juvenile rheumatoid arthritis.1
Kramer et al. have recently proposed the use of functional bracing as an equally effective alternative to traditional hip spica casting for the treatment of pediatric diaphyseal femur fractures. In their study, they found no differences in the correction and maintenance of fracture alignment, time to union and functional outcomes2. The use of a prefabricated and adjustable functional brace was suggested to be better tolerated by patients and their parents as the open design allows for improved hygiene, ease of cleaning, toileting, skin surveillance and improved positional movement.
From a cost-effectiveness analysis perspective, it has been inferred that the overall cost of functional bracing compared to spica casting is lower as it can be applied in the emergency department without the need for a general anesthetic or operating room time. Furthermore, we hypothesize that functional bracing will also decrease visits to orthopedic clinics for cast-related issues which will further decrease the overall costs associated with the treatment of pediatric diaphyseal fractures with a functional brace when compared to a hip spica cast. Having said this, no comprehensive cost-effectiveness analysis studies have been performed to our knowledge and there is minimal literature comparing functional bracing versus spica casting for the treatment of pediatric diaphyseal femur fractures.
This proposed study aims to address this gap by conducting a randomized prospective study comparing functional bracing and spica casting for the treatment of pediatric diaphyseal femur fractures by evaluating maintenance of fracture reduction, time to union, leg-length, functional outcomes, complications, parent/caregiver satisfaction with the treatment as well as performing a supplemental comprehensive cost-effectiveness analysis.
- Conditions
- Pediatric Femur Fracture
- Being tested
- Functional Bracing, Hip Spica Cast
- Keywords
- Functional Brace, Hip Spica Cast, Orthopedic Surgery, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional BracingDevice
Premade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Braces will be applied to participants in the emergency department. As these braces are designed to allow for positional adjustments, if deemed necessary adjustments will be made by the attending orthopaedic surgeon at subsequent follow-up visit(s).
Hip Spica CastDevice
The current standard of care for diaphyseal pediatric hip fractures in children aged 6 months to 5 years old is hip spica casting. A hip spica is a hard cast that covers a child's body from the chest down to their knees or ankles allowing for fracture immobilization to promote healing. Application of the spica cast occurs in the operating room and requires a general anaesthetic. Caring for a child in a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility which makes routine caregiver activities like daily hygiene, toileting, transportation and skin surveillance difficult. Inadequate maintenance of the spica cast may result in skin complications, necessitating extra visits for cast adjustments, or potentially requiring revision casting in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Functional Bracing | Experimental | Premade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Participants who are randomized to the functional bracing group will be administered the functional brace within the emergency department under light procedural sedation. Brace will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging. Receives: Device: Functional Bracing |
| Hip Spica Cast | Active comparator | Participants who are randomized to the spica casting group will undergo casting in the operating room and be given general anesthesia to apply the hip spica cast. Cast will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging. Receives: Device: Hip Spica Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to union/rate of non-union
Assessed by radiographic evidence at clinic follow-up visits.
This will be measuring the length of time and changes in union of bone, and to see if the bone has not healed properly.
Measured: Post-intervention clinical follow-ups up to 1 year
Rates of malunion
Assessed by radiographic evidence at clinic follow-up visits.
Malunion defined as 6 months-2years: > 30 degrees varus/valgus; >30 degrees procurvatum; or >15 mm shortening.
2 years-5 years: > 15 degrees varus/valgus; > 20 degrees procurvatum; or >20 mm shortening.
Measured: Post-intervention clinical follow-ups up to 1 year
Changes in Leg Length
Assessed by radiographic evidence at clinic follow-up visits.
Leg length will be measured using radiographs to determine if there any changes to leg length or discrepancies compared to the contralateral side.
Measured: Post-intervention clinical follow-ups up to 1 year
Flynn Score
Flynn Scoring system will be used to determine final functional results. The Flynn scoring system classifies functional results as: excellent, satisfactory or poor. An excellent result is defined as leg-length discrepancy <1.0cm, femoral malalignment <5 degrees, no pain and no complications. Satisfactory result is defined as leg-length discrepancy <2.0cm, femoral malalignment 5-10 degrees, no pain as well as minor and resolved complications. A poor result is defined as leg-length discrepancy >2.0cm, femoral malalignment >10 degrees, presence of pain and major and lasting complications. Flynn score will be calculated at the 6 week mark and 1 year mark.
Measured: 6 weeks post intervention and at 1 year post-intervention
Number of radiographs and cast clinic visits
This will be used to determine which arm had less radiation from radiographs and less visits with the surgeon.
Measured: Post-intervention clinical follow-ups up to 1 year
Pediatric Outcome Data Collection Instrument (PODCI)
a validated patient-reported quality of life and outcome measure primarily used to assess motor function following orthopedic surgical intervention. Will be completed by the parent at the 6-week and 1-year post-intervention visit and will allow for us to determine subjective outcomes.
Measured: Post-intervention clinical follow-ups up to 1 year
Complications
Includes skin break down issues, pressure sores, repeat operative intervention, cast or brace related issues.
Measured: Post-intervention clinical follow-ups up to 1 year
Parent Satisfaction Survey
The caregiver will complete both the Impact on Family Scales (IFS) and EQ-5D questionnaires. The IFS is a validated 27-item score with Likert-scaling that measures the impact of children's health conditions on his/her family life that addresses four domains: economic impact on family, social impact, familial impact and personal strain/coping. The EQ-5D questionnaire is a brief validated questionnaire designed to evaluate mobility, self-care, usual activities, pain and discomfort as well as anxiety and depression.
Measured: At 6 week and 1 year follow-up.
Economic costs
Direct costs associated with treatment, including materials, equipment, and hospital stays, OR costs, emergency room visit costs will be compared between the two groups.
Measured: Initial presentation to hospital up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric Femur FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)
- Responsible party
- Sponsor
- Investigators
- Lisa Phillips, MD, Principal investigator, University of CalgaryDavid Parsons, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569199
- Sponsor's protocol ID
- REB24-0318
- Status last verified
- Apr 2024
- First submitted
- 21 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen V, Sanders JS, Skaggs DL, Kay RM, Andras LM. (2022). Functional Bracing of Femur Fractures in Young Children Avoids Anesthesia and Spica Casting with Equivalent Outcomes: A Randomized Prospective Study: 2022 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America, 4(3).
Kramer AS, JS, Woon C, Speers D, (2016). Functional Bracing for Treatment of Pediatric Diaphyseal Femur Fractures: An Alternative to Spica Casting: 2016 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America.
Kocher, M., Ciarlo, M., Feroe, A., Dichtel, L., & Traver, J. (2022). Impact on Family Functioning of Immediate Spica Casting for Pediatric Femur Fractures: An Ecological Study: Original Research. Journal of the Pediatric Orthopaedic Society of North America, 4(1).
Rockwood C.A., Beaty J.H., Kasser J.R. Lippincott Williams & Wilkins; 2010. Rockwood and Wilkins' Fractures in Children.
Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP, Ecker ML, Gregg JR, Horn BD, Drummond DS. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am. 2004 Apr;86(4):770-7. doi: 10.2106/00004623-200404000-00015.
PubMed 15069142
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures: A Randomized Prospective Study and Cost-effectiveness Analysis
- ClinicalTrials.gov ID
- NCT06569199
- Acronym / sponsor ID
- REB24-0318
- Conditions
- Pediatric Femur Fracture
- Keywords
- Functional Brace, Hip Spica Cast, Orthopedic Surgery, Pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Aug 2024 (actual)
- 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.
Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting. However, recent studies suggest that functional bracing may offer clinical and financial benefits, yet there's a lack of prospective trials comparing these two treatment methods. This single-center randomized-control trial aims to assess subjective and objective clinical outcomes as well as financial aspects of functional bracing versus spica casting. Functional bracing, proposed as a potentially superior alternative, may address caregiver challenges and reduce costs by avoiding operating room time and hospital admissions. The study will evaluate fracture reduction, time to union, functional outcomes, and caregiver satisfaction. Additionally, a comprehensive cost-effectiveness analysis will be conducted. Ultimately, this research aims to inform clinical decision-making regarding the optimal management of pediatric femur fractures, considering both clinical effectiveness and economic implications.
Detailed description
Pediatric diaphyseal femur fractures are a common orthopedic injury in children, with about one-third occurring in patients under the age of five. These fractures require effective management to promote optimal healing and functional recovery. In the 6-month to 5-year-old age group, diaphyseal femur fractures have traditionally been treated with a hip spica cast. Application of a hip spica cast typically occurs in the operating room (OR) under general anesthesia given that patients must undergo prolonged sedation for cast application. Caring for a child with a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility. This makes routine activities such as daily hygiene, toileting and skin surveillance difficult for caregivers. An ecological study performed by Kocher et al. found that spica casting places a greater burden on family functioning than medical treatment in children with serious chronic medical conditions including diabetes, renal failure, and juvenile rheumatoid arthritis.1
Kramer et al. have recently proposed the use of functional bracing as an equally effective alternative to traditional hip spica casting for the treatment of pediatric diaphyseal femur fractures. In their study, they found no differences in the correction and maintenance of fracture alignment, time to union and functional outcomes2. The use of a prefabricated and adjustable functional brace was suggested to be better tolerated by patients and their parents as the open design allows for improved hygiene, ease of cleaning, toileting, skin surveillance and improved positional movement.
From a cost-effectiveness analysis perspective, it has been inferred that the overall cost of functional bracing compared to spica casting is lower as it can be applied in the emergency department without the need for a general anesthetic or operating room time. Furthermore, we hypothesize that functional bracing will also decrease visits to orthopedic clinics for cast-related issues which will further decrease the overall costs associated with the treatment of pediatric diaphyseal fractures with a functional brace when compared to a hip spica cast. Having said this, no comprehensive cost-effectiveness analysis studies have been performed to our knowledge and there is minimal literature comparing functional bracing versus spica casting for the treatment of pediatric diaphyseal femur fractures.
This proposed study aims to address this gap by conducting a randomized prospective study comparing functional bracing and spica casting for the treatment of pediatric diaphyseal femur fractures by evaluating maintenance of fracture reduction, time to union, leg-length, functional outcomes, complications, parent/caregiver satisfaction with the treatment as well as performing a supplemental comprehensive cost-effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Bracing | Experimental | Device: Functional BracingPremade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Participants who are randomized to the functional bracing group will be administered the functional brace within the emergency department under light procedural sedation. Brace will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging. |
| Hip Spica Cast | Active comparator | Device: Hip Spica CastParticipants who are randomized to the spica casting group will undergo casting in the operating room and be given general anesthesia to apply the hip spica cast. Cast will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 6mo-5 years
- Isolated closed diaphyseal femur fracture
- Parent or caregiver 18 years of age or older who are cognitively able to complete the parent/caregiver satisfaction survey.
Key exclusion criteria (6 listed)
- Patients <6 months or >5 years of age
- Underlying neuromuscular disorders
- Open diaphyseal femur fracture
- Polytrauma
- Medical comorbidities impacting fracture healing
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 |
|---|---|---|
| Functional BracingPremade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Braces will be applied to participants in the emergency department. As these braces are designed to allow for positional adjustments, if deemed necessary adjustments will be made by the attending orthopaedic surgeon at subsequent follow-up visit(s). | Device | Functional Bracing |
| Hip Spica CastThe current standard of care for diaphyseal pediatric hip fractures in children aged 6 months to 5 years old is hip spica casting. A hip spica is a hard cast that covers a child's body from the chest down to their knees or ankles allowing for fracture immobilization to promote healing. Application of the spica cast occurs in the operating room and requires a general anaesthetic. Caring for a child in a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility which makes routine caregiver activities like daily hygiene, toileting, transportation and skin surveillance difficult. Inadequate maintenance of the spica cast may result in skin complications, necessitating extra visits for cast adjustments, or potentially requiring revision casting in the operating room. | Device | Hip Spica Cast |
Primary outcome
Time to union/rate of non-union
Time frame: Post-intervention clinical follow-ups up to 1 year
Assessed by radiographic evidence at clinic follow-up visits. This will be measuring the length of time and changes in union of bone, and to see if the bone has not healed properly.
Rates of malunion
Time frame: Post-intervention clinical follow-ups up to 1 year
Assessed by radiographic evidence at clinic follow-up visits. Malunion defined as 6 months-2years: > 30 degrees varus/valgus; >30 degrees procurvatum; or >15 mm shortening. 2 years-5 years: > 15 degrees varus/valgus; > 20 degrees procurvatum; or >20 mm shortening.
Changes in Leg Length
Time frame: Post-intervention clinical follow-ups up to 1 year
Assessed by radiographic evidence at clinic follow-up visits. Leg length will be measured using radiographs to determine if there any changes to leg length or discrepancies compared to the contralateral side.
Flynn Score
Time frame: 6 weeks post intervention and at 1 year post-intervention
Flynn Scoring system will be used to determine final functional results. The Flynn scoring system classifies functional results as: excellent, satisfactory or poor. An excellent result is defined as leg-length discrepancy <1.0cm, femoral malalignment <5 degrees, no pain and no complications. Satisfactory result is defined as leg-length discrepancy <2.0cm, femoral malalignment 5-10 degrees, no pain as well as minor and resolved complications. A poor result is defined as leg-length discrepancy >2.0cm, femoral malalignment >10 degrees, presence of pain and major and lasting complications. Flynn score will be calculated at the 6 week mark and 1 year mark.
Number of radiographs and cast clinic visits
Time frame: Post-intervention clinical follow-ups up to 1 year
This will be used to determine which arm had less radiation from radiographs and less visits with the surgeon.
Pediatric Outcome Data Collection Instrument (PODCI)
Time frame: Post-intervention clinical follow-ups up to 1 year
a validated patient-reported quality of life and outcome measure primarily used to assess motor function following orthopedic surgical intervention. Will be completed by the parent at the 6-week and 1-year post-intervention visit and will allow for us to determine subjective outcomes.
Complications
Time frame: Post-intervention clinical follow-ups up to 1 year
Includes skin break down issues, pressure sores, repeat operative intervention, cast or brace related issues.
Parent Satisfaction Survey
Time frame: At 6 week and 1 year follow-up.
The caregiver will complete both the Impact on Family Scales (IFS) and EQ-5D questionnaires. The IFS is a validated 27-item score with Likert-scaling that measures the impact of children's health conditions on his/her family life that addresses four domains: economic impact on family, social impact, familial impact and personal strain/coping. The EQ-5D questionnaire is a brief validated questionnaire designed to evaluate mobility, self-care, usual activities, pain and discomfort as well as anxiety and depression.
Economic costs
Time frame: Initial presentation to hospital up to 1 year
Direct costs associated with treatment, including materials, equipment, and hospital stays, OR costs, emergency room visit costs will be compared between the two groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- BackgroundChen V, Sanders JS, Skaggs DL, Kay RM, Andras LM. (2022). Functional Bracing of Femur Fractures in Young Children Avoids Anesthesia and Spica Casting with Equivalent Outcomes: A Randomized Prospective Study: 2022 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America, 4(3).
- BackgroundKramer AS, JS, Woon C, Speers D, (2016). Functional Bracing for Treatment of Pediatric Diaphyseal Femur Fractures: An Alternative to Spica Casting: 2016 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America.
- BackgroundKocher, M., Ciarlo, M., Feroe, A., Dichtel, L., & Traver, J. (2022). Impact on Family Functioning of Immediate Spica Casting for Pediatric Femur Fractures: An Ecological Study: Original Research. Journal of the Pediatric Orthopaedic Society of North America, 4(1).
- BackgroundRockwood C.A., Beaty J.H., Kasser J.R. Lippincott Williams & Wilkins; 2010. Rockwood and Wilkins' Fractures in Children.
- Background: PubMed 15069142Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP, Ecker ML, Gregg JR, Horn BD, Drummond DS. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am. 2004 Apr;86(4):770-7. doi: 10.2106/00004623-200404000-00015.
- Individual participant dataSharing planned: No
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.
Lisa Phillips, MD principal investigator
University of Calgary
David Parsons, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Bracing and Hip Spica Cast in people with Pediatric Femur Fracture, run by University of Calgary at 1 site 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Wajda, MD (4034651996, benjamin.wajda@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to union/rate of non-union (time frame: Post-intervention clinical follow-ups up to 1 year). The study lists 9 primary outcomes in all. 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 NCT06569199, which also lists 5 linked publications.
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 28 Aug 2024.