An observational study in Congenital Pseudarthrosis of Tibia, sponsored by Hunan Children's Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Hunan Children's Hospital · Observational
The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.
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.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 16 observational studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Hunan Children's Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 9 months post-operation
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.
Time frame: 9 months post-operation，the last follow up
Refracture of tibia
The continuity of tibia cortex was disappeared in X ray.
Time frame: Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up
Plan to share: Undecided
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hunan Children's Hospital