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Trial registered on ANZCTR


Registration number
ACTRN12621001286831
Ethics application status
Approved
Date submitted
14/06/2021
Date registered
23/09/2021
Date last updated
19/09/2022
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Thoracoscopic Anterior Vertebral Body Tethering For Scoliosis
Scientific title
Thoracoscopic Anterior Vertebral Body Tethering For Scoliosis: Safety and Efficacy
Secondary ID [1] 304479 0
None
Universal Trial Number (UTN)
U1111-1250-6452
Trial acronym
TAVBTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Scoliosis 322313 0
Condition category
Condition code
Surgery 319980 319980 0 0
Surgical techniques
Musculoskeletal 320707 320707 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thoracoscopic anterior vertebral body tethering.

All patients who meet eligibility criteria will be given the option of thoracoscopic anterior vertebral body tethering. The intervention will be performed by a Fellowship trained Scoliosis Surgeon. Intraoperative spinal cord monitoring will be utilised. The patient will be positioned in the lateral decubitus position with the convex side up. Surgery will be undertaken through 4-7 thoracoscopic portals. Pleura is dissected off the vertebral bodies and segmental vessels diathermied. Radiographic spinal level check is undertaken prior to placement of bicortical transverse vertebral body screws into each vertebra that requires instrumentation. The tether is connected to the screws and tensioned appropriately. A chest drain is placed prior to layered closure. The intervention will be performed once, with a surgical time of approximately 3 hours.
Intervention code [1] 320826 0
Treatment: Surgery
Comparator / control treatment
Spinal fusion.

The intervention will be performed by a Fellowship trained Scoliosis Surgeon. Intraoperative spinal cord monitoring will be utilised. The patient will be positioned prone. Surgery will be undertaken through a posterior approach. Radiographic spinal level check is undertaken prior to placement of pedicle screws, or hooks as appropriate. Appropriate correction prior to connection with rods. Layered closure. Surgical time approximately 3 hours.
Control group
Active

Outcomes
Primary outcome [1] 327858 0
Spinal curve size will be measured from PA (posterior-anterior) scoliosis x-rays.
Timepoint [1] 327858 0
Preoperative, 6 months, 1, 2, 3 and 4 years post-operative.
Primary outcome [2] 328524 0
Spinal curve correction achieved will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.
Timepoint [2] 328524 0
6 months postoperative.
Primary outcome [3] 328525 0
Spinal curve progression will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.
Timepoint [3] 328525 0
1, 2, 3 and 4 years post-operative.
Secondary outcome [1] 396793 0
Operative time.
Timepoint [1] 396793 0
Intraoperative surgical record.
Secondary outcome [2] 399326 0
Blood loss. This will be estimated from the weight of swabs and volume of blood in the suction.
Timepoint [2] 399326 0
Estimated intraoperatively.
Secondary outcome [3] 399327 0
Pulmonary function.
Timepoint [3] 399327 0
Pre- and post-operative spirometry. Post-operative spirometry will be assessed at the 6 month follow-up.
Secondary outcome [4] 399328 0
Number of spinal levels included in construct.
Timepoint [4] 399328 0
Intraoperative surgical record.
Secondary outcome [5] 399329 0
Length of stay. This will be assessed from hospital records.
Timepoint [5] 399329 0
This will be calculated once the patient has been discharged from hospital.
Secondary outcome [6] 399330 0
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.
Timepoint [6] 399330 0
Any time point from the initiation of surgery to the completion of the study.

Eligibility
Key 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
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hyperkyphosis
- Patients who fail to meet indications and inclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective study assessing safety and efficacy of thoracoscopic anterior vertebral body tethering in skeletally immature patients with progressive scoliosis.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
N/A. As this is a prospective study of a new technique looking at treatment outcomes, 30 participants are considered sufficient to effectively identify treatment outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
15/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 23780 0
New Zealand
State/province [1] 23780 0

Funding & Sponsors
Funding source category [1] 308839 0
Self funded/Unfunded
Name [1] 308839 0
Country [1] 308839 0
Primary sponsor type
Individual
Name
Mr. Robert Rowan
Address
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 309756 0
Individual
Name [1] 309756 0
Dr. Matthew Fisk
Address [1] 309756 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country [1] 309756 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308747 0
Central Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 308747 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 308747 0
New Zealand
Date submitted for ethics approval [1] 308747 0
11/03/2021
Approval date [1] 308747 0
10/06/2021
Ethics approval number [1] 308747 0
21/CEN/79

Summary
Brief summary
Idiopathic Scoliosis is a progressive condition, which presents most commonly in early teenage years. If a curve reaches 50° at skeletal maturity it is likely to progress at a rate of 1° or more per year leading to increased deformity and disability in adult life. For this reason, most people with a curve 50° or more are treated with a spinal fusion to correct deformity and prevent progression. Curves 20-40° (with remaining growth) can be treated effectively with bracing and approximately one in three will avoid spinal fusion.

Spinal fusion while effective, is non-physiological and increases stress on non-fused spinal segments. Potential complications include disc degeneration and progressive deformity in unfused segments, and pseudoarthrosis within the fused spine.

Growth modulation is a technique used to treat limb deformities in the paediatric population either by surgically damaging the physis or by placing plates across it. A similar technique has been attempted in the spine by placing staples across the discs. This has been largely unsuccessful as the implants aren’t strong enough to prevent the deformity progressing. An alternative technique has been developed involving thoracoscopic placement of anterior vertebral body screws connected by a flexible tether. This relies on the Heuter-Volkmann law; slowing growth by increasing tension on the convexity of the curve, allowing catch up growth on the concave side. This technique has shown promise preventing >70% of patients meeting the criteria for fusion within 5 years. Currently there is a moderately high reoperation rate in these patients due to over correction or progressive deformity. Further information will help guide indications for this procedure and hopefully lower the reoperation rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111750 0
Mr Robert Rowan
Address 111750 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 111750 0
New Zealand
Phone 111750 0
+64 27 286 7336
Fax 111750 0
Email 111750 0
[email protected]
Contact person for public queries
Name 111751 0
Robert Rowan
Address 111751 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 111751 0
New Zealand
Phone 111751 0
+64 4 385 5999
Fax 111751 0
Email 111751 0
[email protected]
Contact person for scientific queries
Name 111752 0
Robert Rowan
Address 111752 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 111752 0
New Zealand
Phone 111752 0
+64 4 385 5999
Fax 111752 0
Email 111752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be age, gender, and data relating to primary and secondary outcomes, and adverse events.
When will data be available (start and end dates)?
Data will be available at the completion of the trail and available for the following 10 years.
Available to whom?
It will be available on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
No specific analyses.
How or where can data be obtained?
Access subject to approval by Principal Investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.