Clinical trial NCT02640040: The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Official title: The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Pseudarthrosis of Tibia
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guangzhou Women and Children's Medical Center
name: Shenzhen Children's Hospital
name: Tongji Hospital
name: Wuhan Union Hospital, China
name: Wuhan Women and Children's Medical Center
name: Foshan Hospital of Traditional Chinese Medicine
name: Beijing Children's Hospital
name: Dalian Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Kunming Children's Hospital
First posted: 2015-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: whether the tibial has obtained union.
timeFrame: 6 months post-operation
Secondary outcomes:
measure: clinical outcome measurement(Johnston clinical evaluation criterion)
timeFrame: 3,6,9,12,18,24 months post-operation
measure: Refracture of tibia
timeFrame: 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Other outcomes:
measure: Residual Deformity-proximal tibia angulation(range,0°-90°)
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
measure: Residual Deformity-Limb length discrepancy
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
measure: Residual Deformity-ankle valgus angulation(range,0°-90°)
timeFrame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Locations:
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
Study officials:
affiliation: Hunan Children's Hospital
name: Xu Yao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.bpo.0000151054.54732.0b.
citation: 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. doi: 10.1097/01202412-200004000-00003.
citation: 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.
citation: 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. doi: 10.1302/0301-620X.66B3.6373777.
citation: 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.
citation: Zhu GH, Mei HB, He RG, Liu YX, Liu K, Tang J, Wu JY. Combination of intramedullary rod, wrapping bone grafting and Ilizarov's fixator for the treatment of Crawford type IV congenital pseudarthrosis of the tibia: mid-term follow up of 56 cases. BMC Musculoskelet Disord. 2016 Oct 22;17(1):443. doi: 10.1186/s12891-016-1295-1.