Clinical Trial: A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Hunan Children's Hospital

Current Primary Outcome: whether the tibial has obtained union [ Time Frame: 9 months post-operation ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • clinical outcome measurement(Johnston clinical evaluation criterion) [ Time Frame: 9 months post-operation，the last follow up ]
    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.
  • Refracture of tibia [ Time Frame: Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up ]
    The continuity of tibia cortex was disappeared in X ray.


Original Secondary Outcome: Same as current

Information By: Hunan Children's Hospital

Dates:
Date Received: September 6, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: March 17, 2017
Last Verified: March 2017