The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Study Details
Study Description
Brief Summary
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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 Names:
Device: intramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
Other Names:
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 Names:
|
Outcome Measures
Primary Outcome Measures
- whether the tibial has obtained union. [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
- clinical outcome measurement(Johnston clinical evaluation criterion) [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 [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
- Residual Deformity-proximal tibia angulation(range,0°-90°) [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 [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°) [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.
Eligibility Criteria
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.
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Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
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Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
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Parents refused further treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunan Children's Hospital | Changsha | Hunan | China | 410007 |
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
- Principal Investigator: Xu Yao, Hunan Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Johnston CE 2nd. Congenital pseudarthrosis of the tibia: results of technical variations in the charnley-williams procedure. J Bone Joint Surg Am. 2002 Oct;84(10):1799-810.
- Malhotra D, Puri R, Owen R. Valgus deformity of the ankle in children with spina bifida aperta. J Bone Joint Surg Br. 1984 May;66(3):381-5.
- Mathieu L, Vialle R, Thevenin-Lemoine C, Mary P, Damsin JP. Association of Ilizarov's technique and intramedullary rodding in the treatment of congenital pseudarthrosis of the tibia. J Child Orthop. 2008 Dec;2(6):449-55. doi: 10.1007/s11832-008-0139-4. Epub 2008 Oct 28.
- Ohnishi I, Sato W, Matsuyama J, Yajima H, Haga N, Kamegaya M, Minami A, Sato M, Yoshino S, Oki T, Nakamura K. Treatment of congenital pseudarthrosis of the tibia: a multicenter study in Japan. J Pediatr Orthop. 2005 Mar-Apr;25(2):219-24.
- Romanus B, Bollini G, Dungl P, Fixsen J, Grill F, Hefti F, Ippolito E, Tudisco C, Wientroub S. Free vascular fibular transfer in congenital pseudoarthrosis of the tibia: results of the EPOS multicenter study. European Paediatric Orthopaedic Society (EPOS). J Pediatr Orthop B. 2000 Apr;9(2):90-3.
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