Condition category
Musculoskeletal Diseases
Date applied
30/06/2009
Date assigned
10/08/2009
Last edited
07/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Hilali Noordeen

ORCID ID

Contact details

27 Harley Street
London
W1G 9QP
United Kingdom

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

Sponsor information

Organisation

Kspine, Inc. (USA)

Sponsor details

5610 Rowland Rd
Suite 110
Minnetonka
MN
55124
United States of America

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

07/04/2016: Plain English summary added.