Thoracoscopic Anterior Vertebral Body Tethering For Scoliosis

Not Applicable

Recruiting

• Conditions: Idiopathic Scoliosis; Surgery - Surgical techniques; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12621001286831
• Lead Sponsor: Mr. Robert Rowan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:
- Patients treated through CCDHB with a 40-75° flexible idiopathic curve, AND
- Sufficient remaining growth (defined as Risser 0, Sanders stage 2-4).
- Parental consent and patient assent to:
o Procedure
o Follow-up clinical assessment (either in clinic or virtual)
o Follow-up x-rays

Exclusion Criteria

- Hyperkyphosis
- Patients who fail to meet indications and inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal curve size will be measured from PA (posterior-anterior) scoliosis x-rays.[Preoperative, 6 months, 1, 2, 3 and 4 years post-operative.];Spinal curve correction achieved will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.[6 months postoperative.];Spinal curve progression will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.[1, 2, 3 and 4 years post-operative.]

Secondary Outcome Measures

Name	Time	Method
Operative time.[Intraoperative surgical record.];Blood loss. This will be estimated from the weight of swabs and volume of blood in the suction.[Estimated intraoperatively.];Pulmonary function.[Pre- and post-operative spirometry. Post-operative spirometry will be assessed at the 6 month follow-up.];Number of spinal levels included in construct.[Intraoperative surgical record.];Length of stay. This will be assessed from hospital records.[This will be calculated once the patient has been discharged from hospital.];Safety (complications). Intra-operative complications will be recorded by the surgeon. Post-operative complications will be reported by the patient and discussed at each follow-up visit.[Any time point from the initiation of surgery to the completion of the study.]