Clinical Trial: The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Hunan Children's Hospital

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Hunan Children's Hospital

Dates:
Date Received: August 31, 2015
Date Started: August 2015
Date Completion: December 2025
Last Updated: March 17, 2017
Last Verified: March 2017