The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
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|ClinicalTrials.gov Identifier: NCT02640040|
Recruitment Status : Recruiting
First Posted : December 28, 2015
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Pseudarthrosis of Tibia||Device: llizarov external fixation device Device: intramedullary rod fixation Procedure: surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: combined surgery
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
llizarov external fixation device was applied to fix the tibia.
Other Name: llizarov fixator
Device: intramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
Other Name: 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.
Other Name: combined surgery
- whether the tibial has obtained union. [ Time Frame: 6 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.
- clinical outcome measurement(Johnston clinical evaluation criterion) [ Time Frame: 3,6,9,12,18,24 months post-operation ]
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: 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]The continuity of tibia cortex was disappeared in X ray.
- Residual Deformity-proximal tibia angulation(range,0°-90°) [ Time Frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray
- Residual Deformity-Limb length discrepancy [ Time Frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]measurement of the length difference of both tibia in AP and lateral X ray
- Residual Deformity-ankle valgus angulation(range,0°-90°) [ Time Frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]measurement of the angulation between the distal tibia and ankle joint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640040
|Contact: Haibo Mei, M.D.||email@example.com|
|Contact: Kewei Wang, M.Dfirstname.lastname@example.org|
|Hunan Children's Hospital||Recruiting|
|Changsha, Hunan, China, 410007|
|Contact: Haibo Mei, M.D. 008613975197731 email@example.com|
|Contact: Guanghui Zhu, M.D. 008313875864343 firstname.lastname@example.org|
|Principal Investigator:||Xu Yao||Hunan Children's Hospital|