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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorFoshan Hospital of Traditional Chinese Medicine

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Old fracture, more than 8 days.

Open injury

Type S-H III or IV or V

Multiple fractures and injuries

Trial design

Design model

Parallel

Treatments tested in this trial

  • Closed reduction

    Procedure/Surgery

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

  • Open reduction

    Procedure/Surgery

    Open reduction and internal fixation

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Less or equal to 2mmPlacebo comparator 1 intervention
Group B: Between 2-4mmPlacebo comparator 2 interventions
Group C: Greater than 4mmActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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)

Secondary outcomes

1

Early closure of epiphysis

Yes/No

Time frame
3 months,6 months,9months,12months
2

Limb shortening

The length difference between the two tibia

Time frame
1 year,2year,3year,4year,5year
3

Ankle joint function and the change over time

Use AOFAS Ankle-Hindfoot Scale to score

Time frame
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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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