Femoral Shaft FractureNCT04311866
Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants
A study testing Synthetic pants and Spica cast in people with Femoral Shaft Fracture and Pediatric ALL, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Femoral pediatric shaft fractures are a common orthopedic injury. Conservative treatment is still the preferred method by orthopedic surgeons. The walking spica cast is used in patients between 1 year old and 6 years old, in patients with isolated and low-energy fractures. Read more about this study
- Who is it for?
- Ages 18 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Shaft Fracture, Pediatric ALL
- What is being tested?
- Synthetic pants and Spica cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jan 2020to 31 Jan 2023
- 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 18 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Simple fractures (transverse or short oblique fracture)
- Less than 2 cm of shortening
- Independent walking ability
- Closed fractures
- Isolated shaft fractures
- Low energy
- Written informed consent by the parents
Who cannot join
- Polytraumatized patients
- Cranial trauma or spinal cord injury
- Articular extension of the fracture
- History of femoral shaft fracture
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: Comparative Study in the Clinical Efficacy, Satisfaction and Complications While Treating Walking Spica Cast vs Synthetic Pants in the Management of Pediatric Low-energy Femoral Shaft Fracture. Randomized Clinical Trial
Femoral pediatric shaft fractures are a common orthopedic injury. Conservative treatment is still the preferred method by orthopedic surgeons. The walking spica cast is used in patients between 1 year old and 6 years old, in patients with isolated and low-energy fractures. The use of synthetic materials is preferred (fiber glass) for resistance, durability and low weight makes them optimal.
Read the detailed description
Femoral shaft fractures are the most common orthopedic injury among the femoral fractures in pediatric patients. Approximately 70% of them, are femoral shaft fractures. In the management of this fractures, child abuse has to be discarded, considering age, history, physical examination and radiographic findings.(1) Gross et al suggest that up to 80% of the children that have not yet learned to walk, have been victims of abuse. Moreover, it is important to discard any other condition that could make the child prone to fractures, myelomeningocele, cerebral palsy, osteogenesis imperfecta, non-ossifying fibroma, etc.
Once the diagnosis is made, several variables have to be brought to account, in order to select a treatment method: associated injuries, fracture characteristics, the capability of obtaining an appropriate reduction, familiar situation and costs.
Conservative treatment is still the preferred method by orthopedic surgeons because of its cost and effectivity. Pavlik harness are used in newborns and children up to 6-12 months, it maintains the fracture aligned, it is comfortable and avoids the risk of complications associated to the cast contact with the skin.(1,2) The walking spica cast is used in patients between 1 and 6 years old. Generally this method of treatment is indicated isolated and low-energy fractures.(1) Patients in this group of age with high-energy or comminuted fractures, may require traction prior to the application of the cast. Also, positive Telescope Test may make the patient candidate to traction. In this test, under general anesthesia, a gentile force is applied along the femur, if a 3 or more centimeters shortening is present, the patient has a 20-fold risk of unacceptable shortening.(3) For the application of a cast in femoral fractures, a flexion of 90° in the hip and knee joints is preferred, because this position relaxes the flexor muscles and the hamstrings, besides, it has a lower incidence of loss of reduction and more easy easiness for transportation.(4) in previous studies there has been a loss of reduction 9 times greater in patients immobilized with the knee in less of 50°. The risk of loss of reduction is elevated twice for each centimeter of initial shortening. (1 cm: 12%; 3 cm: 50%)(5) A long cast is applied on the affected extremity, while a gentile traction is maintained and a valgus mold is applied on the fracture site. The remaining part of the cast is applied to the line of the nipples. Caution has to be taken when applying traction to the extremity because the pressure on the popliteus fossa and peroneal nerve. The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strength to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar.
A radiographic follow-up during the first 10 days is important because the position of the reduction during the first 7 through 10 days, predicts in a important manner the final result. The cast is retired at 6 - 8 weeks. The rehabilitation therapy is not usually necessary and the parents need to be advised about a residual limp, which can last a few months.
The patient and his family´s life quality has an important role in this kind of injuries. The immediate application of a spica cast substitutes the bed traction prior to the cast application.(4) Multiple adequations have to be made: vehicle safety and transportation, daily supervision, education, home mobility, and hygiene. The home transportation has been identified as the most problematic issue and as a solution to this problem, families have to acquire a wheel chair. (1,4) Hygiene represents a prevalent issue, of minor importance, and parents should be educated about this problem. The position of the cast at 90°-90° may help to solve this issue.
Surprisingly, the need to be absent at work is not the most mentioned problem by parents,. An average of 3 weeks out of work was needed by parents to take care of their child.
Education and learning of the child is vital because of the development and socialization process that takes place during this age. (4) A home tutor works adequately, even though this represents a economic burden to the family.
Activity recovery after retrieval of the cast, such as running and playing starts until 25 days. Physical education should be postponed for one month after retrieval. (4) Surgical treatment is indicated in patients in school age, because of the quality life burden the prolonged immobilization represents. Among those treatments, the options are external fixation, intramedullary flexible nails, and plate fixation.
- Conditions
- Femoral Shaft Fracture, Pediatric ALL
- Being tested
- Synthetic pants, Spica cast
- Keywords
- femoral pediatric shaft fractures, walking spica cast, synthetic pants
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic pantsDevice
The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strenght to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar.
Spica castDevice
The use of the spica cast is a standard practice for the management of the femoral shaft fractures, however its use, under some circumstances has been related to a wrong management of the cast, auto-retrieval, patient discomfort, and a difficult situation trying to maintain personal hygiene for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Spica cast | Active comparator | Standard practice for the management of the femoral shaft fractures. Receives: Device: Spica cast |
| Synthetic fabric | Experimental | Offer resistance, durability and low weight to treatment of femoral shaft fractures Receives: Device: Synthetic pants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone consolidation
Evaluate the bone consolidation during the follow-up, with standard two position x-ray (anteroposterior and lateral) according to Stans classification. When grade 0 represents the absence of indentifiable bone callus; grade 1 primary bone callus with little or no periosteal new bone formation; grade 2 periosteal new bone formation on both sides of bone, and grade 3 represents periosteal new bone formation in three or four sides of the bone
Measured: 42 days
Secondary outcomes (2)
Bone angulation
Evaluate and compare the angulation in all planes (varus, valgus, antecurvature or recurvatum) in two standard x-ray images (anteroposterior and lateral)
Measured: 42 days
Bone shortening
The shortening it was measured in centimeters in two standard X-ray projections, and compared between the two groups
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start4 Jan 2020
- Primary completion31 Aug 2022
- Study completion31 Jan 2023
Why it stopped: Lack of material for treatment of the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Femoral 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
- Investigators
- Carlos Acosta-Olivo, PhD, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311866
- Sponsor's protocol ID
- OR19-00002
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flynn JM, Schwend RM. Management of pediatric femoral shaft fractures. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):347-59. doi: 10.5435/00124635-200409000-00009.
PubMed 15469229Anglen JO, Choi L. Treatment options in pediatric femoral shaft fractures. J Orthop Trauma. 2005 Nov-Dec;19(10):724-33. doi: 10.1097/01.bot.0000192294.47047.99.
PubMed 16314721Buehler KC, Thompson JD, Sponseller PD, Black BE, Buckley SL, Griffin PP. A prospective study of early spica casting outcomes in the treatment of femoral shaft fractures in children. J Pediatr Orthop. 1995 Jan-Feb;15(1):30-5. doi: 10.1097/01241398-199501000-00008.
PubMed 7883924Hughes BF, Sponseller PD, Thompson JD. Pediatric femur fractures: effects of spica cast treatment on family and community. J Pediatr Orthop. 1995 Jul-Aug;15(4):457-60. doi: 10.1097/01241398-199507000-00009.
PubMed 7560034Illgen R 2nd, Rodgers WB, Hresko MT, Waters PM, Zurakowski D, Kasser JR. Femur fractures in children: treatment with early sitting spica casting. J Pediatr Orthop. 1998 Jul-Aug;18(4):481-7.
PubMed 9661858Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.
PubMed 10739280Epps HR, Molenaar E, O'connor DP. Immediate single-leg spica cast for pediatric femoral diaphysis fractures. J Pediatr Orthop. 2006 Jul-Aug;26(4):491-6. doi: 10.1097/01.bpo.0000217724.08794.e4.
PubMed 16791068
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study in the Clinical Efficacy, Satisfaction and Complications While Treating Walking Spica Cast vs Synthetic Pants in the Management of Pediatric Low-energy Femoral Shaft Fracture. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04311866
- Acronym / sponsor ID
- OR19-00002
- Conditions
- Femoral Shaft Fracture, Pediatric ALL
- Keywords
- femoral pediatric shaft fractures, walking spica cast, synthetic pants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of material for treatment of the patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 17 Mar 2020 (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.
Femoral pediatric shaft fractures are a common orthopedic injury. Conservative treatment is still the preferred method by orthopedic surgeons. The walking spica cast is used in patients between 1 year old and 6 years old, in patients with isolated and low-energy fractures. The use of synthetic materials is preferred (fiber glass) for resistance, durability and low weight makes them optimal.
Detailed description
Femoral shaft fractures are the most common orthopedic injury among the femoral fractures in pediatric patients. Approximately 70% of them, are femoral shaft fractures. In the management of this fractures, child abuse has to be discarded, considering age, history, physical examination and radiographic findings.(1) Gross et al suggest that up to 80% of the children that have not yet learned to walk, have been victims of abuse. Moreover, it is important to discard any other condition that could make the child prone to fractures, myelomeningocele, cerebral palsy, osteogenesis imperfecta, non-ossifying fibroma, etc.
Once the diagnosis is made, several variables have to be brought to account, in order to select a treatment method: associated injuries, fracture characteristics, the capability of obtaining an appropriate reduction, familiar situation and costs.
Conservative treatment is still the preferred method by orthopedic surgeons because of its cost and effectivity. Pavlik harness are used in newborns and children up to 6-12 months, it maintains the fracture aligned, it is comfortable and avoids the risk of complications associated to the cast contact with the skin.(1,2) The walking spica cast is used in patients between 1 and 6 years old. Generally this method of treatment is indicated isolated and low-energy fractures.(1) Patients in this group of age with high-energy or comminuted fractures, may require traction prior to the application of the cast. Also, positive Telescope Test may make the patient candidate to traction. In this test, under general anesthesia, a gentile force is applied along the femur, if a 3 or more centimeters shortening is present, the patient has a 20-fold risk of unacceptable shortening.(3) For the application of a cast in femoral fractures, a flexion of 90° in the hip and knee joints is preferred, because this position relaxes the flexor muscles and the hamstrings, besides, it has a lower incidence of loss of reduction and more easy easiness for transportation.(4) in previous studies there has been a loss of reduction 9 times greater in patients immobilized with the knee in less of 50°. The risk of loss of reduction is elevated twice for each centimeter of initial shortening. (1 cm: 12%; 3 cm: 50%)(5) A long cast is applied on the affected extremity, while a gentile traction is maintained and a valgus mold is applied on the fracture site. The remaining part of the cast is applied to the line of the nipples. Caution has to be taken when applying traction to the extremity because the pressure on the popliteus fossa and peroneal nerve. The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strength to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar.
A radiographic follow-up during the first 10 days is important because the position of the reduction during the first 7 through 10 days, predicts in a important manner the final result. The cast is retired at 6 - 8 weeks. The rehabilitation therapy is not usually necessary and the parents need to be advised about a residual limp, which can last a few months.
The patient and his family´s life quality has an important role in this kind of injuries. The immediate application of a spica cast substitutes the bed traction prior to the cast application.(4) Multiple adequations have to be made: vehicle safety and transportation, daily supervision, education, home mobility, and hygiene. The home transportation has been identified as the most problematic issue and as a solution to this problem, families have to acquire a wheel chair. (1,4) Hygiene represents a prevalent issue, of minor importance, and parents should be educated about this problem. The position of the cast at 90°-90° may help to solve this issue.
Surprisingly, the need to be absent at work is not the most mentioned problem by parents,. An average of 3 weeks out of work was needed by parents to take care of their child.
Education and learning of the child is vital because of the development and socialization process that takes place during this age. (4) A home tutor works adequately, even though this represents a economic burden to the family.
Activity recovery after retrieval of the cast, such as running and playing starts until 25 days. Physical education should be postponed for one month after retrieval. (4) Surgical treatment is indicated in patients in school age, because of the quality life burden the prolonged immobilization represents. Among those treatments, the options are external fixation, intramedullary flexible nails, and plate fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spica cast | Active comparator | Device: Spica castStandard practice for the management of the femoral shaft fractures. |
| Synthetic fabric | Experimental | Device: Synthetic pantsOffer resistance, durability and low weight to treatment of femoral shaft fractures |
Who may qualify
- Ages
- 18 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Simple fractures (transverse or short oblique fracture)
- Less than 2 cm of shortening
- Independent walking ability
- Closed fractures
- Isolated shaft fractures
Key exclusion criteria (4 listed)
- Polytraumatized patients
- Cranial trauma or spinal cord injury
- Articular extension of the fracture
- History of femoral shaft fracture
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 |
|---|---|---|
| Synthetic pantsThe use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strenght to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar. | Device | Synthetic fabric |
| Spica castThe use of the spica cast is a standard practice for the management of the femoral shaft fractures, however its use, under some circumstances has been related to a wrong management of the cast, auto-retrieval, patient discomfort, and a difficult situation trying to maintain personal hygiene for the patient. | Device | Spica cast |
Primary outcome
Bone consolidation
Time frame: 42 days
Evaluate the bone consolidation during the follow-up, with standard two position x-ray (anteroposterior and lateral) according to Stans classification. When grade 0 represents the absence of indentifiable bone callus; grade 1 primary bone callus with little or no periosteal new bone formation; grade 2 periosteal new bone formation on both sides of bone, and grade 3 represents periosteal new bone formation in three or four sides of the bone
2 secondary outcomes
Bone angulation
Time frame: 42 days
Bone shortening
Time frame: 42 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Results publication: PubMed 15469229Flynn JM, Schwend RM. Management of pediatric femoral shaft fractures. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):347-59. doi: 10.5435/00124635-200409000-00009.
- Results publication: PubMed 16314721Anglen JO, Choi L. Treatment options in pediatric femoral shaft fractures. J Orthop Trauma. 2005 Nov-Dec;19(10):724-33. doi: 10.1097/01.bot.0000192294.47047.99.
- Results publication: PubMed 7883924Buehler KC, Thompson JD, Sponseller PD, Black BE, Buckley SL, Griffin PP. A prospective study of early spica casting outcomes in the treatment of femoral shaft fractures in children. J Pediatr Orthop. 1995 Jan-Feb;15(1):30-5. doi: 10.1097/01241398-199501000-00008.
- Results publication: PubMed 7560034Hughes BF, Sponseller PD, Thompson JD. Pediatric femur fractures: effects of spica cast treatment on family and community. J Pediatr Orthop. 1995 Jul-Aug;15(4):457-60. doi: 10.1097/01241398-199507000-00009.
- Results publication: PubMed 9661858Illgen R 2nd, Rodgers WB, Hresko MT, Waters PM, Zurakowski D, Kasser JR. Femur fractures in children: treatment with early sitting spica casting. J Pediatr Orthop. 1998 Jul-Aug;18(4):481-7.
- Results publication: PubMed 10739280Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.
- Results publication: PubMed 16791068Epps HR, Molenaar E, O'connor DP. Immediate single-leg spica cast for pediatric femoral diaphysis fractures. J Pediatr Orthop. 2006 Jul-Aug;26(4):491-6. doi: 10.1097/01.bpo.0000217724.08794.e4.
- Individual participant dataSharing planned: No
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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.
Carlos Acosta-Olivo, PhD principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic pants and Spica cast in people with Femoral Shaft Fracture and Pediatric ALL, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 7 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. 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 Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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?
Bone consolidation (time frame: 42 days). 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 NCT04311866, which also lists 7 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 24 Mar 2023.