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

Congenital Pseudarthrosis of Tibia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02896114
• Other study ID #: HN03
• Status: Recruiting
• Start date: September 2016
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Hunan Children's Hospital
• Contact: Haibo Mei
• Phone: 008613975197731
• Email: meihaibo8[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Pseudarthrosis of Tibia
• Pseudarthrosis

Locations

Country	Name	City	State
China	Hunan Children's Hospital	Changsha	Hunan

Sponsors (11)

Lead Sponsor	Collaborator
Hunan Children's Hospital	Beijing Children's Hospital, Children's Hospital of Chongqing Medical University, Dalian Children's Hospital, Foshan Hospital of Traditional Chinese Medicine, Guangzhou Women and Children's Medical Center, Kunming Children's Hospital, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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