ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

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]

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]

Spinal curve size will be measured from PA (posterior-anterior) scoliosis x-rays.

Timepoint [1]

Preoperative, 6 months, 1, 2, 3 and 4 years post-operative.

Primary outcome [2]

Spinal curve correction achieved will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.

Timepoint [2]

6 months postoperative.

Primary outcome [3]

Spinal curve progression will be measured from postoperative PA (posterior-anterior) scoliosis x-rays.

Timepoint [3]

1, 2, 3 and 4 years post-operative.

Secondary outcome [1]

Operative time.

Timepoint [1]

Intraoperative surgical record.

Secondary outcome [2]

Blood loss. This will be estimated from the weight of swabs and volume of blood in the suction.

Timepoint [2]

Estimated intraoperatively.

Secondary outcome [3]

Pulmonary function.

Timepoint [3]

Pre- and post-operative spirometry. Post-operative spirometry will be assessed at the 6 month follow-up.

Secondary outcome [4]

Number of spinal levels included in construct.

Timepoint [4]

Intraoperative surgical record.

Secondary outcome [5]

Length of stay. This will be assessed from hospital records.

Timepoint [5]

This will be calculated once the patient has been discharged from hospital.

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Mr. Robert Rowan

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Dr. Matthew Fisk

Address [1]

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committees (HDEC)

Ethics committee address [1]

Ministry of Health 
133 Molesworth Street 
PO Box 5013 
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/03/2021

Approval date [1]

10/06/2021

Ethics approval number [1]

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

Mr Robert Rowan

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 27 286 7336

Fax

robert.rowan@ccdhb.org.nz

Contact person for public queries

Name

Robert Rowan

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 385 5999

Fax

robert.rowan@ccdhb.org.nz

Contact person for scientific queries

Name

Robert Rowan

Address

Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 385 5999

Fax

robert.rowan@ccdhb.org.nz

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 (robert.rowan@ccdhb.org.nz).

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.

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