Plain English Summary
Background and study aims.
Adolescent Idiopathic Scoliosis (AIS) is a condition that causes the spine to curve sideways. It can be treated with surgery to correct the curvature, where the spine is straightened using rods attached to the spine by screws, hooks and/or wires. The aim of this study is to find out how much force is required to move the spine to midline. We also wish to find out how much spine movement can be achieved with a maximum force of 40 lbs at one point of attachment.
Who can participate?
Patients between 8 and 16 years old with idiopathic scoliosis (curvature of the spine with no known cause) with a single curve requiring surgical treatment via a posterior (back) only surgical approach.
What does the study involve?
While the patient is undergoing surgery, force measurements are taken to determine the force necessary to move the patient’s curved spine toward midline, and the amount of curve correction at a maximum of 40 lbs of force. This takes about 10 minutes. After these measurements are taken, no follow up is required.
What are the possible benefits and risks of participating?
The risks were considered to be very low, but as with all surgeries, it is possible that some risks could develop. The main risk was that while pulling the spine toward the middle of your back, the cable, screw or rod could break or dislodge and cause damage to nerves, bone or muscle. The force used to pull the spine toward the middle will be applied gradually to minimize this risk.
Where is the study run from?
Royal National Orthopaedic Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2009 to September 2009
Who is funding the study?
Kspine Inc. (USA)
Who is the main contact?
Diane Burnside
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Kspine 101
Study information
Scientific title
A non-randomised study to measure the force required to move the spine towards midline in adolescent idiopathic scoliosis patients
Acronym
Study hypothesis
This study will measure the force required to move the spine toward midline in patients with adolescent idiopathic scoliosis.
Ethics approval
East London and The City/Research Ethics Committee 1, 01/07/2009, ref: 09/H0703/70
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Adolescent idiopathic scoliosis (AIS)
Intervention
Force measurements will be taken to determine the force necessary to move a curved spine toward midline. The total duration of treatment for this study will be approximately 10 minutes. After these measurements are taken, no follow up is required.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Force measurements to determine the force necessary to move a curved spine toward midline, measured near the beginning of the surgery and completed before the surgery to correct the patient's scoliosis is begun.
Secondary outcome measures
Amount of curve correction at a maximum of 40 lbs of force, measured near the beginning of the surgery and completed before the surgery to correct the patient's scoliosis is begun.
Overall trial start date
13/07/2009
Overall trial end date
29/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient has idiopathic scoliosis with a single curve requiring surgical treatment via a posterior only surgical approach
2. The curve appears to be compliant as evidenced by standing bending x-rays and/or the ability of the surgeon to improve the curve with external manipulation
3. Patient must be between 8 and 16 years old, either sex
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Patient has an underlying neurologic or congenital pathology involving the spine in addition to idiopathic scoliosis
2. Patient has local or systemic infection
3. Patient is participating in any other device or drug study
4. Patient is grossly obese with a body mass index greater than 40 kg/m^2
5. Patient has a history of communicable disease such as human immunodeficiency virus (HIV), hepatitis, etc.
Recruitment start date
13/07/2009
Recruitment end date
29/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
27 Harley Street
London
W1G 9QP
United Kingdom
Funders
Funder type
Industry
Funder name
Kspine, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary