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Completed

NCT Number: NCT05190393

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hemivertebra resection on convex side

Procedure

Patients were used hemivertebra resection procedure to treat congenital cervical scoliosis.

concave distraction group

Procedure

Patients were used distraction and lateral opening procedure to treat congenital cervical scoliosis.

Primary outcomes

  1. the structural Cobb angle

    Time frame: one week pre operation

    the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected

  2. the structural Cobb angle

    Time frame: one week after surgery

    the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected

  3. the structural Cobb angle

    Time frame: 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

  4. distal compensatory Cobb angle

    Time frame: one week pre operation

    the small curve without vertebral deformities

  5. distal compensatory Cobb angle

    Time frame: one week after surgery

    the small curve without vertebral deformities

  6. distal compensatory Cobb angle

    Time frame: through study completion, an average of 1 year

    the small curve without vertebral deformities

  7. mandibular incline

    Time frame: one week pre operation

    the angle between the horizontal line and the line through the mandibular angles on both sides

  8. mandibular incline

    Time frame: one week after surgery

    the angle between the horizontal line and the line through the mandibular angles on both sides

  9. mandibular incline

    Time frame: through study completion, an average of 1 year

    the angle between the horizontal line and the line through the mandibular angles on both sides

  10. clavicle angle

    Time frame: one week pre operation

    the angle between the horizontal line and the line through the clavicular distal end on both sides

  11. clavicle angle

    Time frame: one week after surgery

    the angle between the horizontal line and the line through the clavicular distal end on both sides

  12. clavicle angle

    Time frame: 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 outcomes

  1. blood loss

    Time frame: during operation

    blood loss during operation

  2. surgical time duration

    Time frame: during operation

    surgical time duration during operation

  3. complications

    Time frame: peroperative period

    complications during and after operation

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.