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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in Mexico

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.

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 groups in NCT04311866
Study groupRoleWhat they receive
Spica castActive comparatorStandard practice for the management of the femoral shaft fractures.
Receives: Device: Spica cast
Synthetic fabricExperimentalOffer 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted17 Mar 2020
  2. Study start4 Jan 2020
  3. Primary completion31 Aug 2022
  4. Study completion31 Jan 2023

Why it stopped: Lack of material for treatment of the patients

Resources

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)
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 15469229
  • Anglen 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 16314721
  • Buehler 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 7883924
  • Hughes 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 7560034
  • Illgen 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 9661858
  • Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.

    PubMed 10739280
  • Epps 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

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.

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