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Tibial FracturesNCT02723825

Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture Prognosis

A study testing Closed reduction and Open reduction in people with Tibial Fractures and Epiphyseal Fracture, run by Foshan Hospital of Traditional Chinese Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis injury, because of the complex damage mechanism and often leads to growth retardation and joint deformity, the patient's physical and mental damage larger; also epiphysis injury restoration requires higher standard and more… Read more about this study

Who is it for?
Ages 10 to 16 years
Conditions the study is for
Tibial Fractures, Epiphyseal Fracture
What is being tested?
Closed reduction and Open reduction
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
Mar 2016to Dec 2026
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 10 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The fresh fractures, within 7 days
  • Closed fracture
  • Type S-H I or II
  • Unilateral limb fracture, no other parts of the fractures or damage
  • On the other side of the lower extremity was normal
  • Epiphysis is not closed and Risser sign 0-IV degrees
  • No metabolic, genetic sex diseases etc.
  • Signed informed consent

Who cannot join

  • Old fracture, more than 8 days.
  • Open injury
  • Type S-H III or IV or V
  • Multiple fractures and injuries
  • The contralateral limb was abnormal
  • Epiphyseal closure or Risser sign V degree
  • There are metabolic or genetic diseases
  • Do not agree to sign informed consent, not on time to follow-up.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yueming Guo, benco contact

0086-13827710333

guo_yueming2008@126.com

Zhiyuan Wang, master contact

0086-18928613202

milo-8008@126.com

About this study

Official title: A Multi Center Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture

Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis injury, because of the complex damage mechanism and often leads to growth retardation and joint deformity, the patient's physical and mental damage larger; also epiphysis injury restoration requires higher standard and more difficult to fixed, and methods are being actively explored to improve the curative effect and prevent the sequelae. Our hospital pediatric department of orthopedics expects to conduct prospective study through multi center to study the influence of factors such as the tibia epiphysis fracture of distal injury's mechanism and initial and residual displacement and treatment etc. on patients' prognosis of late growth disorders, joint deformity and ankle function.

Methods and analysis: To join the multi center research collaboration group of the south pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital, Guangzhou city women and children's Medical Center), the formation of multi center research network, writing program, including the inclusion and exclusion criteria, grouping and follow-up time, method. Participating in the working group meeting, listening to the expert's opinions to improve research programs, formulate the tracking table of distal tibial epiphyseal fracture, and starting to implement after approved by the medical ethics committee of each hospital. The hospital is responsible for supervision in the whole process of project implementation, and building the real-time reporting system, and it is the responsible person of pediatric department of orthopedics of Foshan Hospital of TCM to do the random inspection. After the completion of data collection, data entry and statistical analysis conducted by the pediatric department of orthopedics in Foshan Hospital of TCM.

Read more

Ethics and promotion: The research is approved by the hospital medical ethics committee of the south pediatric orthopedics multi center cooperative research group. Single blind method is performed for children in the course of the study. Research data is shared by all participating units and joints promotion of research results.

Registration: To register and update the study on the United States NIH ClinicalTrials.gov website.

Read the detailed description

Introduction Epiphyseal and Epiphyseal plate are all immature skeletal growth mechanism, the epiphyseal plate injury also known as epiphyseal injuries, fracture line through the epiphyseal plate can also spread to the epiphysis or metaphysis. Epiphyseal plate's connection is weaker than normal tendon, ligament, or joint capsule, so the children of epiphyseal injuries are common. Distal tibial epiphyseal injuries accounted for about 25%- 38% of the epiphyseal injuries. Because after the injury of the distal epiphysis of the tibia injury often leads to growth retardation and joint deformity, the patient's physical and mental damage larger. Because of the complexity of the pathogenesis of this disease, and there are many related factors. The research of related factors of the disease is benefit to evaluate the prognosis, and conducive to early intervention, benefit to avoid the occurrence or development of severe sequelae, has positive significance in clinical practice.

Because the disease is related to many factors, and the serious cases of this disease are less, the multi center cooperation is conducive to the collection of sufficient cases to analyze and achieve the objective and effective results, so establish the multi center topic.

Design and overview In epiphyseal growth stage, the epiphyseal plate connects weaker than normal tendons, ligaments, or joint capsule, so epiphyseal plate is more vulnerable to be injured. Every epiphyseal complex is composed of each epiphysis and epiphyseal plate, its growth and blood supply are interdependent, which any damage may reinforce each other. The Ranvier district around the epiphysis has the ability to ossify. It is easy to form a bone bridge and growth arrest and angular deformity after injury. Epiphyseal fracture is belongs to intra-articular fractures, such as not timely reset, prone to complications. About 15% of children with fractures involving the epiphyseal injuries, the number of boys are more than girls, as the chance of injury is more, this is because men's epiphyseal plate closure time later than women's. X-ray manifestation of epiphyseal injuries, while more complex, but the epiphyseal and backbone of the corresponding position of the dislocation and epiphyseal line broadening is the most important, a slight shift and (or) epiphyseal line broadening is the most easy to be ignored, should X-ray the healthy side at the same time.

In theory, fracture involving the epiphyseal growth plate and articular surface is easily occurred in two kinds of complications: first distal tibia epiphyseal premature closure causes valgus or varus malleolus and limb shortening; the second is the distal tibial articular surface damage causes the ankle joint degenerative changes and bone arthritis. According to Salter Harris bone epiphysis injury types were divided into five types, and in the distal tibial epiphysis injury I, II type are common in clinic. Therefore, the biggest problem is the formation of the bone bridge, early epiphyseal closure, resulting in growth arrest, angular deformity. From the current literature, the most important related factors are in injured mechanism and degree of displacement Leary JT's research shows: the initial fracture displacement and damage mechanism for determining development of PPC after the fracture of epiphysis of distal end of tibia may have a significant predictive value. Ankle fracture Lauge - Hansen parting is ankle fracture classification system put forward by Lauge - Hansen doctors in 1950 according to the damage position and violence that cause deformity, able to quickly assess the damage mechanism of 90% - 95% cases, and has been widely used. Its clinical significance lies in: 1 find fracture and classify injury and be able to make the diagnosis of ligament injury. 2 guide manipulative reduction. The general principle is: closed manipulative reduction and fracture have the opposite force mechanism.3 for the distal tibial epiphysis fracture, can also understand the severity of the injury and the existence of the risk of soft tissue embedded. Therefore, we think, it is necessary to research on the lauge Hansen classification and correlation of prognosis. The relationship between the fracture displacement and correlation of prognosis is in the extent of the shift, the vast majority of doctors think less than 2mm shift can be accepted, and to shift more than 2mm, there are different opinions. Gonc U et al think ankle joint fracture usually involving the tibia and fibular epiphyses in children and adolescents. Although they do not occur with growth arrest, but may still lead to traumatic arthritis. Therefore, for more than 2 mm of residual displacement there is a need for surgical treatment. And David podeszwa Da thinks is greater than 3mm residual displacement often means embedded with soft tissue, may increase early closure of epiphysis of probability. Russo F the most pessimistic, he thinks a shift of the S - H type Ⅱ tibial distal epiphyseal fracture is a challenging problem. Rate of epiphyseal early closure is very high (> 43%). Even if incision and anatomical repositioning, removal of embedded organization, also cannot reduce the incidence of PPC, and may increase the risk of subsequent surgery.

Considered in the design, what JOHN A.O GDEN points out "epiphyseal separation should be reset as soon as possible, each delay 1 d will increase the difficulty as it repair soon. For type II epiphyseal injuries after more than 10 d, if you don't use excessive force can not make manual reduction success, however it could damage the cartilage epiphyseal plate and damage the early osteotylus, therefore, for type II epiphyseal injuries that see a doctor later (after (7-10 d) ,had better let it be malunion, and cannot use powerful technique or surgical repositioning, lest cause obvious epiphyseal growth stopped, heals the residual deformities can then use the appropriate correction osteotomy". This view is widely agreed. In the inclusion criteria we chose cases that injury within 7 days. In addition, the Risser ilium epiphyseal ossification sign is a commonly used method for determination of the bone age, JiShiJun's pediatric bone science thinks " ossification of the crista iliaca is usually in conformity with the stop of limbs' longitudinal growth", this is the important index for determining growth potential in include and exclude criteria in this topic, so there is reason to believe that when a Risser sign V degrees distal tibial epiphyseal growth stopped, fixed limb length and Angle.

Grouping Divide the patients into groups according to the residual displacement of the fracture after the first manual reduction.

Group A: the residual displacement is less than or equal to 2mm, select closed reduction and external fixation (such as splint, plaster or traction, frame of external fixation, etc.) Group B: the residual shift is between 2-4mm, manual reset once again, as still between 2-4mm, the cooperation of each unit to choose closed reduction.

Group C: the residual shift is between 2-4mm, manual reset once again, as still between 2-4mm, the cooperation of each unit to choose closed reduction.

Group D: residual displacement is greater than 4mm, open reduction and internal fixation.

Evaluation criteria According to OVADIA et al' evaluation criteria: excellent, Joint function restore basic consistent with that of the healthy side, without any symptoms, or joint flexion range is more than 75% of the healthy side, mild sore and swollen after walking, restore normal work; Good, joint flexion range is 50% - 70% of the healthy side, joint is mild soreness, markedly swollen after walking, unable to attend the heavy physical work; Can, joint flexion range is 25% - 50% of the healthy side, joint is obvious swelling and pain, difficulty walking, and accept joint arthrodesis at the end; Poor, joint range is less than 25% of the healthy side, joint is markedly swollen, pain, stiffness, unable to walk, and accept joint arthrodesis at the end.

Data collection To hospital after conventional laboratory tests, X-ray the anteroposterior and lateral film of the affected side, the contralateral tibiofibula (including ankle) and posteroanterior radiograph of pelvis, scan the affected ankle with CT (fracture displacement measurement, tibial epiphyseal radius vector and the transverse diameter and cross section). Select cases according to the inclusion criteria, exclusion criteria Divide the patients into groups according to the X-ray films of the affected side, the degree of displacement after measuring residual displacement after the first manual reduction.

Treated according to the grouping, 3 months, 6 months, 9 months, 1-5 years after surgery follow-up.Between 3 to 12 months, each time X-ray films were taken on both ankles, observe whether there are the early closure of epiphysis; 1 to 5 years, each time we measure whether the tibia shortening or angle, OVADIA efficacy assessment and ankle function evaluation (using the table of "AOFAS Ankle-Hindfoot Scale "), until 5 years long and the distal tibial epiphyseal closure of the other side.

Organization and implementation The projects will be written by Foshan Hospital of TCM pediatric orthopaedic and submitted to the south pediatric orthopaedic multicenter study group. The project design will be discussed, modified by the hospital experts. The projects will be submitted for approval by the hospital medical ethics committee. Then the various units sign a cooperation agreement after the experts determine and clear scientific, the feasibility of this topic, and the study will be registered on the United States NIH ClinicalTrials.gov website and updated according to the situation.

In the process of implementation, the southern pediatric orthopaedic multicenter study group will communicate and consult with each other to timely solve the problems and difficulties appeared in the research through the email, WeChat and phone, even on a business trip and other means of collaboration, besides the plenary meeting each quarter, to ensure the implementation of this project.

Data collection and management Statistic analysis Foshan Hospital of TCM pediatric orthopaedic formulated the tibial distal epiphyseal fracture tracking table and send it every cooperative unit to record whether there is patients epiphyseal closed early, and if there is, record the shortening length of the affected limb and angle of angulation deformity, and record the ankle limb function (valgus, varus and back stretch, plantar flexion), assess the pain index and rank according to the evaluation criteria of OVADIA etc. During the implementation of the project, the data should be filled in the table timely, accurately and objectively by cooperative unit, to keep a record of each item shall be seriously not omissions, and regular follow-up. At the same time, set up the monitor, regularly or randomly go to the test center to check and ensure that the original data is real and effective. Accounting personnel chose by Foshan Hospital of TCM to do the double entry, ensure the data entry is correct. If in doubt, the monitor will investigate then return the data. Use the SPSS16.0 to input the data, and describe normal measurement data with mean + / - standard deviation, average between the group by t test, counting data, with chi-square, finally with Logistic regression model to analysis multi-factor.

Being tested
Closed reduction, Open reduction
Keywords
Distal tibia, fractures, epiphyses, children
Medical subject headings
Tibial Fractures, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed reductionProcedure or surgery

    Also called Manipulative reduction and External fixation

    Treated with Manipulatio, using plywood, gypsum or external fixation support to fixed

  • Open reductionProcedure or surgery

    Open reduction and internal fixation

Study groups in NCT02723825
Study groupRoleWhat they receive
Less or equal to 2mmPlacebo comparatorthe residual displacement is less than or equal to 2mm
Receives: Procedure: Closed reduction
Between 2-4mmPlacebo comparatorthe residual shift is between 2-4mm, manual reset once again, as still between 2-4mm
Receives: Procedure: Closed reduction; Procedure: Open reduction
Greater than 4mmActive comparatorthe residual displacement is greater than 4mm
Receives: Procedure: Open reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation criteria of OVADIA and the change over time

    Excellent, Joint function restore basic consistent with that of the healthy side, without any symptoms, or joint flexion range is more than 75% of the healthy side, mild sore and swollen after walking, restore normal work; Good, joint flexion range is 50% - 70% of the healthy side, joint is mild soreness, markedly swollen after walking, unable to attend the heavy physical work; Can, joint flexion range is 25% - 50% of the healthy side, joint is obvious swelling and pain, difficulty walking, and accept joint arthrodesis at the end; Poor, joint range is less than 25% of the healthy side, joint is markedly swollen, pain, stiffness, unable to walk, and accept joint arthrodesis at the end.

    Measured: 1 year,2year,3year,4year,5year(We think that develops gradually of limb shortening or angle because of early epiphyseal closure will result in a lowered grad of OVADIA)

Secondary outcomes (3)
  1. Early closure of epiphysis

    Yes/No

    Measured: 3 months,6 months,9months,12months

  2. Limb shortening

    The length difference between the two tibia

    Measured: 1 year,2year,3year,4year,5year

  3. Ankle joint function and the change over time

    Use AOFAS Ankle-Hindfoot Scale to score

    Measured: 1 year,2year,3year,4year,5year(We think that develops gradually of limb shortening or angle because of early epiphyseal closure will also result in a lower score of AOFAS Ankle-Hindfoot Scale)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2026 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723825
Sponsor's protocol ID
456074139
Status last verified
Mar 2016
First submitted
18 Mar 2016
Last updated
31 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Russo F, Moor MA, Mubarak SJ, Pennock AT. Salter-Harris II fractures of the distal tibia: does surgical management reduce the risk of premature physeal closure? J Pediatr Orthop. 2013 Jul-Aug;33(5):524-9. doi: 10.1097/BPO.0b013e3182880279.

    PubMed 23752150
  • Leary JT, Handling M, Talerico M, Yong L, Bowe JA. Physeal fractures of the distal tibia: predictive factors of premature physeal closure and growth arrest. J Pediatr Orthop. 2009 Jun;29(4):356-61. doi: 10.1097/BPO.0b013e3181a6bfe8.

    PubMed 19461377
  • Podeszwa DA, Mubarak SJ. Physeal fractures of the distal tibia and fibula (Salter-Harris Type I, II, III, and IV fractures). J Pediatr Orthop. 2012 Jun;32 Suppl 1:S62-8. doi: 10.1097/BPO.0b013e318254c7e5.

    PubMed 22588106
  • Gonc U, Kayaalp A. [Ankle fractures in children and adolescents]. Acta Orthop Traumatol Turc. 2004;38 Suppl 1:127-37. Turkish.

    PubMed 15187469

Questions about this trial

What is this clinical trial studying?

A study testing Closed reduction and Open reduction in people with Tibial Fractures and Epiphyseal Fracture, run by Foshan Hospital of Traditional Chinese Medicine.

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 8 inclusion and 8 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Yueming Guo, benco (0086-13827710333, guo_yueming2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation criteria of OVADIA and the change over time (time frame: 1 year,2year,3year,4year,5year(We think that develops gradually of limb shortening or angle because of early epiphyseal closure will result in a lowered grad of OVADIA)). 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 NCT02723825, which also lists 4 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 31 Mar 2016.

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