Clinical trial NCT05190393: Comparison of Techniques Between Concave Distraction and Convex Resection in the Treatment of Congenital Cervical Scoliosis
Official title: Comparison of Techniques Between Concave Distraction and Convex Resection in the Treatment of Congenital Cervical Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Scoliosis Due to Bony Malformation
Cervical Scoliosis
Keywords: Congenital cervical scoliosis
hemivertebra resection
distraction and lateral opening
spinal fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital cervical scoliosis were enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the structural Cobb angle
timeFrame: one week pre operation
measure: the structural Cobb angle
timeFrame: one week after surgery
measure: the structural Cobb angle
timeFrame: through study completion, an average of 1 year
measure: distal compensatory Cobb angle
timeFrame: one week pre operation
measure: distal compensatory Cobb angle
timeFrame: one week after surgery
measure: distal compensatory Cobb angle
timeFrame: through study completion, an average of 1 year
measure: mandibular incline
timeFrame: one week pre operation
measure: mandibular incline
timeFrame: one week after surgery
measure: mandibular incline
timeFrame: through study completion, an average of 1 year
measure: clavicle angle
timeFrame: one week pre operation
measure: clavicle angle
timeFrame: one week after surgery
measure: clavicle angle
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: blood loss
timeFrame: during operation
measure: surgical time duration
timeFrame: during operation
measure: complications
timeFrame: peroperative period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yu Sun, MD
role: STUDY_CHAIR
References: