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Trial record 1 of 1 for:    NCT02640040
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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
Sponsor:
Collaborators:
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
Tongji Hospital
Wuhan Union Hospital, China
Wuhan Women and Children's Medical Center
Foshan Hospital of Traditional Chinese Medicine
Beijing Children's Hospital
Dalian Children's Hospital
Children's Hospital of Chongqing Medical University
Kunming Children's Hospital
Information provided by (Responsible Party):
Hunan Children's Hospital

Tracking Information
First Submitted Date  ICMJE August 31, 2015
First Posted Date  ICMJE December 28, 2015
Last Update Posted Date March 20, 2017
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02640040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2015)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Official Title  ICMJE The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Brief Summary The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Pseudarthrosis of Tibia
Intervention  ICMJE
  • 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
  • Procedure: surgery
    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
Study Arms  ICMJE 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.
Interventions:
  • Device: llizarov external fixation device
  • Device: intramedullary rod fixation
  • Procedure: surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia

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.
  • Parents refused further treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Haibo Mei, M.D. 008613975197731 meihaibo8@163.com
Contact: Kewei Wang, M.D 008673185600908 wangkw78@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02640040
Other Study ID Numbers  ICMJE HN02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hunan Children's Hospital
Study Sponsor  ICMJE Hunan Children's Hospital
Collaborators  ICMJE
  • Guangzhou Women and Children's Medical Center
  • Shenzhen Children's Hospital
  • Tongji Hospital
  • Wuhan Union Hospital, China
  • Wuhan Women and Children's Medical Center
  • Foshan Hospital of Traditional Chinese Medicine
  • Beijing Children's Hospital
  • Dalian Children's Hospital
  • Children's Hospital of Chongqing Medical University
  • Kunming Children's Hospital
Investigators  ICMJE
Principal Investigator: Xu Yao Hunan Children's Hospital
PRS Account Hunan Children's Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP