Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000316808
Ethics application status
Approved
Date submitted
13/03/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the performance of a pedicle screw system for correction and fusion of Adolescent Idiopathic Scoliosis
Scientific title
A prospective, multi-center, non-randomized post approval study to evaluate the performance of the Kspine Pedicle Screw System for correction and fusion of Adolescent Idiopathic Scoliosis
Secondary ID [1] 280111 0
Nil
Universal Trial Number (UTN)
U1111-1129-0368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent idiopathic scoliosis 286028 0
Condition category
Condition code
Musculoskeletal 286218 286218 0 0
Other muscular and skeletal disorders
Surgery 286236 286236 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical implantation of the pedicle screw system in adolescent patients to correct curvature of the spine. The system is left in place until skeletal maturity and adequate curve correction. Depending on the maturity of the patient when implanted, will determine the length of time the system will be left in place. It is assumed most patients will have the device for 2 - 5 years. The surgical implantation procedure is just like that of the standard pedicle screw systems that are currently used in surgery using a posterior approach. The system uses pedicle screws, rods and cables to align the spine. The procedure will last about 2 - 4 hours depending on the number of pedicle screws that are placed.
Intervention code [1] 284441 0
Treatment: Devices
Intervention code [2] 284454 0
Treatment: Surgery
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286692 0
Evaluate device performance by assessing the magnitude of the main thoracic Cobb angle in the coronal view of an x-ray image at baseline and compare to that at 6 months post-index implantation x-ray image.
Timepoint [1] 286692 0
Baseline, 6 months
Primary outcome [2] 286693 0
Device safety as freedom from serious device and/or procedural-related adverse events within 6 months post-index implantation. Possible adverse events are those that may currently happen with any deformity surgery of the thoracic region where a pedicle screw system is used. They may include but are not limited to: implant failure including malpositon, migration, bending and/or fracture, early or late loosening of the implanted system. These are all monitoring at the imlplant procedure and with imaging at various stages of the study.
Timepoint [2] 286693 0
Post-implant to 6 months
Secondary outcome [1] 296470 0
Assess the magnitude of the Cobb angle in the coronal view of a x-ray image at baseline and 12 and 24 months
Timepoint [1] 296470 0
12 and 24 months
Secondary outcome [2] 296471 0
Evaluate Quality of Life using the SRS 22r quesionnaire
Timepoint [2] 296471 0
baseline, 6 months, 12 months, 24 months
Secondary outcome [3] 296472 0
Evaluate device safety as freedom from serious device and/or procedure-related adverse events 12 and 24 months post index procedure. Possible adverse events are those that may currently happen with any deformity surgery of the thoracic region where a pedicle screw system is used. They may include but are not limited to: implant failure including malpositon, migration, bending and/or fracture, early or late loosening of the implanted system. These are all monitoring at the imlplant procedure and with imaging at various stages of the study.
Timepoint [3] 296472 0
12 and 24 months

Eligibility
Key inclusion criteria
Subject has AIS with Lenke type 1A or 1B main thoracic curve
Cobb angle between 40 and 65 degrees
Curve must reduce to greater than or equal to 50 % on lateral bend x-ray
Subject does not have hyper-kyphotic thoras defined as greater than or equal to 50 degree angle on lateral x-ray
Sanders score 3 - 7
Minimum age
11 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hyper-kyphotic thorax (greater than or equal to 50 degrees)
History of metabolic bone disease affecting bone structure
Previous spine surgery
Active infection
Pregnant or planning to become pregnant during the study

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)
Trial patients AIS that may meet the inclusion/exclusion criteria will be enrolled in the trial based on the results of the clinical assessments at baseline. A imaging core lab will determine in the patient meets in the imaging criteria to be implanted on the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4194 0
Slovakia
State/province [1] 4194 0
Bratislava
Country [2] 4195 0
Bosnia and Herzegovina
State/province [2] 4195 0
Sarajevo
Country [3] 4196 0
United Kingdom
State/province [3] 4196 0
England
Country [4] 4197 0
Turkey
State/province [4] 4197 0
Bursa

Funding & Sponsors
Funding source category [1] 284874 0
Commercial sector/Industry
Name [1] 284874 0
Kspine Inc
Country [1] 284874 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kspine
Address
5610 Rowland Road
Suite 110
Minnetonka, Minnesota 55343
Country
United States of America
Secondary sponsor category [1] 283753 0
None
Name [1] 283753 0
Address [1] 283753 0
Country [1] 283753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286861 0
Eticka Komisia Lekarskej Fakulty Univerzity, Komenskeho A Fakultnej Nemocnice
Ethics committee address [1] 286861 0
S Poliklinikou Bratislava
Pracovisko Ruzinov
Ruzinovska 6, 82606 Bratislava
Slovak Republic
Ethics committee country [1] 286861 0
Slovakia
Date submitted for ethics approval [1] 286861 0
30/12/2011
Approval date [1] 286861 0
10/01/2012
Ethics approval number [1] 286861 0

Summary
Brief summary
The pedicle screw system is a posterior implantable system to stabilize spinal segments and promote fusion. The pedicle screw system will be utilized to facilitate deformity correction in adolescent patients with scoliosis. The study will look at the amount of correction of the curve from x-ray images at baseline and compare those to x-ray images of the spine post-implant and at follow-up visits. The study will also evaluate the safety profile of the device and collect information on any serious device and/or procedural adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33896 0
Address 33896 0
Country 33896 0
Phone 33896 0
Fax 33896 0
Email 33896 0
Contact person for public queries
Name 17143 0
Diane Burnside
Address 17143 0
5610 Rowland Road
Suite 110
Minnetonka, Minnesota, 55343
Country 17143 0
United States of America
Phone 17143 0
+1 952 465 0618
Fax 17143 0
+1 952 465 0601
Email 17143 0
[email protected]
Contact person for scientific queries
Name 8071 0
Diane Burnside
Address 8071 0
5610 Rowland Road
Suite 110
Minnetonka, Minnesota, 55343
Country 8071 0
United States of America
Phone 8071 0
+1 952 465 0618
Fax 8071 0
+1 952 465 0601
Email 8071 0
[email protected]

No information has been provided regarding IPD availability


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.