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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

Brief Summary:
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.

Condition or disease Intervention/treatment Phase
Congenital Pseudarthrosis of Tibia Device: llizarov external fixation device Device: intramedullary rod fixation Procedure: surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Haibo Mei, M.D. 008613975197731 meihaibo8@163.com
Contact: Kewei Wang, M.D 008673185600908 wangkw78@163.com

Locations
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China, Hunan
Hunan Children's Hospital Recruiting
Changsha, Hunan, China, 410007
Contact: Haibo Mei, M.D.    008613975197731    meihaibo8@163.com   
Contact: Guanghui Zhu, M.D.    008313875864343    zgh5650@163.com   
Sponsors and Collaborators
Hunan Children's Hospital
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
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Principal Investigator: Xu Yao Hunan Children's Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hunan Children's Hospital
ClinicalTrials.gov Identifier: NCT02640040     History of Changes
Other Study ID Numbers: HN02
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries