Clinical trial NCT02896114: A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China
Official title: A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China: a Muti-centre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Pseudarthrosis of Tibia
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guangzhou Women and Children's Medical Center
name: Shenzhen Children's Hospital
name: Tongji Hospital
name: Wuhan Union Hospital, China
name: Wuhan Women and Children's Medical Center
name: Foshan Hospital of Traditional Chinese Medicine
name: Beijing Children's Hospital
name: Dalian Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Kunming Children's Hospital
First posted: 2016-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: whether the tibial has obtained union
timeFrame: 9 months post-operation
Secondary outcomes:
measure: clinical outcome measurement(Johnston clinical evaluation criterion)
timeFrame: 9 months post-operation，the last follow up
measure: Refracture of tibia
timeFrame: Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
Study officials:
affiliation: Hunan Children's Hospital
name: Xu Yao
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/01.bpo.0000151054.54732.0b.
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. doi: 10.1097/01202412-200004000-00003.
citation: 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.