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

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ClinicalTrials.gov Identifier: NCT02723825
Recruitment Status : Not yet recruiting
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Yueming Guo, Foshan Hospital of Traditional Chinese Medicine

Brief 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 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.


Condition or disease Intervention/treatment Phase
Tibial Fractures Epiphyseal Fracture Procedure: Closed reduction Procedure: Open reduction Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi Center Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture
Study Start Date : March 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Less or equal to 2mm
the residual displacement is less than or equal to 2mm
Procedure: Closed reduction
Treated with Manipulatio, using plywood, gypsum or external fixation support to fixed
Other Name: Manipulative reduction and External fixation

Placebo Comparator: Between 2-4mm
the residual shift is between 2-4mm, manual reset once again, as still between 2-4mm
Procedure: Closed reduction
Treated with Manipulatio, using plywood, gypsum or external fixation support to fixed
Other Name: Manipulative reduction and External fixation

Procedure: Open reduction
Open reduction and internal fixation

Active Comparator: Greater than 4mm
the residual displacement is greater than 4mm
Procedure: Open reduction
Open reduction and internal fixation




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. Early closure of epiphysis [ Time Frame: 3 months,6 months,9months,12months ]
    Yes/No

  2. Limb shortening [ Time Frame: 1 year,2year,3year,4year,5year ]
    The length difference between the two tibia

  3. Ankle joint function 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 also result in a lower score of AOFAS Ankle-Hindfoot Scale) ]
    Use AOFAS Ankle-Hindfoot Scale to score



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723825


Contacts
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Contact: Yueming Guo, benco 0086-13827710333 guo_yueming2008@126.com
Contact: Zhiyuan Wang, master 0086-18928613202 milo-8008@126.com

Sponsors and Collaborators
Foshan Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Yueming Guo, benco Director of pediatric orthopaedic

Publications of Results:
Other Publications:
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Responsible Party: Yueming Guo, Director, Head of Pediatric Department of Orthopedics,Clinical Professor of Guangzhou University of TCM, Foshan Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02723825     History of Changes
Other Study ID Numbers: 456074139
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yueming Guo, Foshan Hospital of Traditional Chinese Medicine:
Distal tibia
fractures
epiphyses
children

Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries