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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Scoliosis Due to Bony Malformation; Cervical Scoliosis
• Intervention / Treatment: Procedure: hemivertebra resection on convex side; Procedure: concave distraction group

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital cervical scoliosis were enrolled.

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Convex resection group; Patients were used hemivertebra resection procedure on convex side to treat congenital cervical scoliosis.	Procedure: hemivertebra resection on convex side; Patients were used hemivertebra resection procedure to treat congenital cervical scoliosis.
Concave distraction group; Patients were used distraction and lateral opening procedure on concave side to treat congenital cervical scoliosis, without hemivertebra resection.	Procedure: concave distraction group; Patients were used distraction and lateral opening procedure to treat congenital cervical scoliosis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	blood loss during operation	during operation
surgical time duration	surgical time duration during operation	during operation
complications	complications during and after operation	peroperative period

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Yu Sun, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: spinal fusion; Congenital cervical scoliosis; hemivertebra resection; distraction and lateral opening
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: PUTHCCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No