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

NCT02723825 | Not Yet Recruiting

• 1 other identifier: 456074139
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tibial Fractures; Epiphyseal Fracture

Keywords

Distal tibia; fractures; epiphyses; children

Outcome Measures

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.

  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)

• Early closure of epiphysis

  3 months，6 months,9months,12months

• Limb shortening

  1 year,2year,3year,4year,5year

• Ankle joint function and the change over time

  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)

Study Arms (3)

Less or equal to 2mm

PLACEBO COMPARATOR

the residual displacement is less than or equal to 2mm

Procedure: Closed reduction

Between 2-4mm

PLACEBO COMPARATOR

the residual shift is between 2-4mm, manual reset once again, as still between 2-4mm

Procedure: Closed reduction; Procedure: Open reduction

Greater than 4mm

ACTIVE COMPARATOR

the residual displacement is greater than 4mm

Procedure: Open reduction

Interventions

Closed reduction PROCEDURE

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

Also known as: Manipulative reduction and External fixation

Between 2-4mm; Less or equal to 2mm

Open reduction PROCEDURE

Open reduction and internal fixation

Between 2-4mm; Greater than 4mm

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foshan Hospital of Traditional Chinese Medicine: lead

Related Publications (4)

• 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.

  PMID: 23752150 BACKGROUND

• 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.

  PMID: 19461377 BACKGROUND

• 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.

  PMID: 22588106 RESULT

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

  PMID: 15187469 RESULT

MeSH Terms

Conditions

Tibial Fractures; Fractures, Bone

Interventions

Closed Fracture Reduction; Open Fracture Reduction

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Yueming Guo, benco

  Director of pediatric orthopaedic

  STUDY CHAIR

Central Study Contacts

Yueming Guo, benco

CONTACT

0086-13827710333; guo_yueming2008@126.com

Zhiyuan Wang, master

CONTACT

0086-18928613202; milo-8008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Pediatric Department of Orthopedics,Clinical Professor of Guangzhou University of TCM

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2016

Record last verified: 2016-03