Scoliosis correction force measurement study
| ISRCTN | ISRCTN71590683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71590683 |
| Secondary identifying numbers | Kspine 101 |
- Submission date
- 30/06/2009
- Registration date
- 10/08/2009
- Last edited
- 07/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
27 Harley Street
London
W1G 9QP
United Kingdom
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A non-randomised study to measure the force required to move the spine towards midline in adolescent idiopathic scoliosis patients |
| Study objectives | This study will measure the force required to move the spine toward midline in patients with adolescent idiopathic scoliosis. |
| Ethics approval(s) | East London and The City/Research Ethics Committee 1, 01/07/2009, ref: 09/H0703/70 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 13/07/2009 |
| Completion date | 29/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 13/07/2009 |
| Date of final enrolment | 29/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W1G 9QP
United Kingdom
Sponsor information
Industry
5610 Rowland Rd
Suite 110
Minnetonka, MN
55124
United States of America
"ROR" |
https://ror.org/00mwvbx98 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/04/2016: Plain English summary added.
