Comparison of Techniques Between Concave Distraction and Convex Resection in the Treatment of Congenital Cervical Scoliosis

Completed

• Conditions: Cervical Scoliosis; Congenital Scoliosis Due to Bony Malformation
• Interventions: Procedure: concave distraction group; Procedure: hemivertebra resection on convex side

• Registration Number: NCT05190393
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To treat congenital cervical scoliosis, previous literature introduced surgical technique, like hemivertebra resection by anterior and posterior approach. Although this technique is effective, it has a lot of disadvantages. So investigators introduce another surgical technique.

Detailed Description

Although hemivertebra resection technique can obtain satisfactory clinical outcome, it has its disadvantages. Because of the presence of vertebral arteries, the procedure of cervical hemivertebra resection is not only difficult and risky, but also time and labor consuming. The operation is a great challenge to the skill, physical strength and energy of the surgical team. Meanwhile, hemivertebra resection and compression on convex side may lead to iatrogenic foraminal stenosis and increase the incidence of nerve root palsy at the corresponding segment after surgery. The shortening of the convex side may further aggravate the patient's existing short neck deformity, which is not conducive to the recovery of patient's appearance. Therefore, our department pioneer a new surgical technique to avoid hemivertebra resection in 2015, which is distraction and lateral opening on concave side. This technique extends the concave side through intervertebral space where the concave apex locates or adjacent intervertebral space to achieve the purpose of scoliosis correction. The avoidance of hemivertebra resection significantly reduces the difficulty and risk of the surgery. This procedure tries to make up for the patient's congenital anatomical deficiency and lengthen the concave side. Although there is no need to expose vertebral artery, preoperative CTA(computed tomography angiography) should be performed routinely to determine whether there is abnormality in vertebral artery and whether it will interfere with the distraction on concave side and the placement of prosthesis.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• the presence of torticollis caused by congenital cervical scoliosis (defined as a Cobb angle of >10°)
• operation and follow-up were performed in our hospital

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Exclusion Criteria

• Patients with other causes of torticollis appearance, such as muscular torticollis, ocular torticollis, neurogenic torticollis, etc.
• Patients with other spinal deformity or disease, such as cervical kyphosis or kyphoscoliosis, congenital deformity of middle and lower thoracic vertebra, lumbar vertebra, ankylosing spondylitis, severe ossification of cervical posterior longitudinal ligament, etc.
• Cervical infectious diseases, cervical primary or metastatic tumor
• Have a history of spinal trauma or surgery
• Imaging data are incomplete or of poor quality.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concave distraction group	concave distraction group	Patients were used distraction and lateral opening procedure on concave side to treat congenital cervical scoliosis, without hemivertebra resection.
Convex resection group	hemivertebra resection on convex side	Patients were used hemivertebra resection procedure on convex side to treat congenital cervical scoliosis.

Primary Outcome Measures

Name	Time	Method
mandibular incline	through study completion, an average of 1 year	the angle between the horizontal line and the line through the mandibular angles on both sides
distal compensatory Cobb angle	through study completion, an average of 1 year	the small curve without vertebral deformities
the structural Cobb angle	through study completion, an average of 1 year	the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
clavicle angle	through study completion, an average of 1 year	the angle between the horizontal line and the line through the clavicular distal end on both sides

Secondary Outcome Measures

Name	Time	Method
complications	peroperative period	complications during and after operation
blood loss	during operation	blood loss during operation
surgical time duration	during operation	surgical time duration during operation

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China