A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China: a Muti-centre Study

The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.

Study Overview

• Status: Unknown
• Conditions: Congenital Pseudarthrosis of Tibia

Detailed Description

The study aims to evaluate the current surgical treatment and its result for Congenital Pseudarthrosis of tibia (CPT)in children in China. A retrospective study will be conducted with around 150 patients at 11 centers in China. This study will use available registry data from a defined time period of Jan 2006-Dec 2014. The treatment method will be recorded. The bone union rate and the refracture rate were calculated to evaluate the final result of several surgical treatment.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410007
      • Recruiting
      • Hunan Children's Hospital
      • Contact: Kewei Wang, M.D.; Phone Number: 008673185600908; Email: wangkw78@163.com
      • Principal Investigator: Haibo Mei, M.D.
      • Sub-Investigator: An Yan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.

Description

Inclusion Criteria:

The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.

Exclusion Criteria:

• Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
• Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
• Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whether the tibial has obtained union	Ohnishi criterion: Degree of union was evaluated by the findings on radiographs and classified into three grades( Ohnishi criterion): union, delayed union, and nonunion. Radiographic union was defined as possessing continuity of bone density between the fragments without obvious radiolucent zone between them and possessing cortex-bridging fragments with sufficient thickness and radiodensity on both anteroposterior and lateral radiographs. Delayed union was defined as a process of healing that was slow but was progressing. Nonunion was defined by the healing process that had completely ceased.	9 months post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome measurement(Johnston clinical evaluation criterion)	Johnston clinical evaluation criterion of Congenital Pseudarthrosis of Tibia (CPT): The outcome was classified as grade 1 when there was unequivocal union with full weight-bearing function and maintenance of alignment requiring no additional surgical treatment; grade 2 when there was equivocal union with useful function, with the limb protected by a brace, and/or valgus or sagittal bowing for which additional surgery was required or anticipated; and grade 3 when there was persistent nonunion or refracture, requiring full-time external support for pain and/or instability.	9 months post-operation，the last follow up
Refracture of tibia	The continuity of tibia cortex was disappeared in X ray.	Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up

Collaborators and Investigators

• Sponsor: Hunan Children's Hospital
• Collaborators: Tongji Hospital; Wuhan Union Hospital, China; Beijing Children's Hospital; Kunming Children's Hospital; Guangzhou Women and Children's Medical Center; Shenzhen Children's Hospital; Children's Hospital of Chongqing Medical University; Wuhan Women and Children's Medical Center; Foshan Hospital of Traditional Chinese Medicine; Dalian Children's Hospital
• Investigators: Principal Investigator: Xu Yao, Hunan Children's Hospital

Publications and helpful links

General Publications

• Ohnishi I, Sato W, Matsuyama J, Yajima H, Haga N, Kamegaya M, Minami A, Sato M, Yoshino S, Oki T, Nakamura K. Treatment of congenital pseudarthrosis of the tibia: a multicenter study in Japan. J Pediatr Orthop. 2005 Mar-Apr;25(2):219-24. doi: 10.1097/01.bpo.0000151054.54732.0b.
• Romanus B, Bollini G, Dungl P, Fixsen J, Grill F, Hefti F, Ippolito E, Tudisco C, Wientroub S. Free vascular fibular transfer in congenital pseudoarthrosis of the tibia: results of the EPOS multicenter study. European Paediatric Orthopaedic Society (EPOS). J Pediatr Orthop B. 2000 Apr;9(2):90-3. doi: 10.1097/01202412-200004000-00003.
• Mathieu L, Vialle R, Thevenin-Lemoine C, Mary P, Damsin JP. Association of Ilizarov's technique and intramedullary rodding in the treatment of congenital pseudarthrosis of the tibia. J Child Orthop. 2008 Dec;2(6):449-55. doi: 10.1007/s11832-008-0139-4. Epub 2008 Oct 28.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Ununited; Pseudarthrosis
• Other Study ID Numbers: HN03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided