An interventional study of llizarov external fixation device and intramedullary rod fixation in Congenital Pseudarthrosis of Tibia, sponsored by Hunan Children's Hospital. Recruiting 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 · Not applicable, Interventional, and Treatment
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis. The combined surgery includes sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and appliance of llizarov external fixation device. Bone uion rate,average time of healing, Healing index, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 22 across 25 interventional 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.
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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.
combined surgery for enrolled patients with CPT(Congenital Pseudarthrosis of Tibia): sleeve resection of the pathological soft tissues, intramedullary rod fixation, packaged lilac bone autograft,and llizarov external fixation device installation.
Device: llizarov external fixation device · Device: intramedullary rod fixation · Procedure: surgery
llizarov external fixation device was applied to fix the tibia.
Also known as: llizarov fixator
retrograde intramedullary rod was applied to stabilize the tibia.
Also known as: intramedullary rodding
combined surgery for enrolled patients with CPT: sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and llizarov external fixation device installation.
Also known as: combined surgery
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: 6 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: 3,6,9,12,18,24 months post-operation
Refracture of tibia
The continuity of tibia cortex was disappeared in X ray.
Time frame: 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-proximal tibia angulation(range,0°-90°)
measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-Limb length discrepancy
measurement of the length difference of both tibia in AP and lateral X ray
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-ankle valgus angulation(range,0°-90°)
measurement of the angulation between the distal tibia and ankle joint.
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Plan to share: Undecided
The record gives a start of Aug 2015, a primary completion of Dec 2025 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.
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Hunan Children's Hospital