ScoliosisPhase 4NCT00768313
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
A Phase 4 study testing titanium rod and ultra strength stainless steel rod in people with Scoliosis, run by Queen's University at 1 site in Canada.
Trial summary
There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- titanium rod and ultra strength stainless steel rod
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 10-20;
- presenting with a progressive lenke type 1A, N; or
- type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle
Who cannot join
- rigid scoliosis requiring a three column release or osteotomy;
- patients that can not have pedicle screw instrumentation due to technical concerns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.
There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.
Read the detailed description
screw purchase was to be recorded but study has been withdrawn.
- Conditions
- Scoliosis
- Being tested
- titanium rod, ultra strength stainless steel rod
- Keywords
- scoliosis correction rod strength adolescent
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium rodDevice
comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
ultra strength stainless steel rodDevice
Also called Expedium ultra strength stainless steel rod (220KSI).
interventions involving rods of various strength to treat scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
percent correction in both frontal and sagittal planes for idiopathic scoliosis
Measured: pre-op, 3, 6, 12, 24 months
Secondary outcomes (1)
screw purchase
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, Dr. Daniel Borschneck, Queen's University
- Investigators
- Daniel Borschneck, MD, Principal investigator, Queen's Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768313
- Sponsor's protocol ID
- DB-012008
- Status last verified
- Aug 2019
- First submitted
- 7 Oct 2008
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.
- ClinicalTrials.gov ID
- NCT00768313
- Acronym / sponsor ID
- DB-012008
- Conditions
- Scoliosis
- Keywords
- scoliosis correction rod strength adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.
Detailed description
screw purchase was to be recorded but study has been withdrawn.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- aged 10-20;
- presenting with a progressive lenke type 1A, N; or
- type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle
Key exclusion criteria (2 listed)
- rigid scoliosis requiring a three column release or osteotomy;
- patients that can not have pedicle screw instrumentation due to technical concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| titanium rodcomparison of rods of varying yield strengths and their ability to hold correction of scoliosis. | Device | – |
| ultra strength stainless steel rodAlso: Expedium ultra strength stainless steel rod (220KSI).interventions involving rods of various strength to treat scoliosis | Device | – |
Primary outcome
percent correction in both frontal and sagittal planes for idiopathic scoliosis
Time frame: pre-op, 3, 6, 12, 24 months
1 secondary outcome
screw purchase
Time frame: intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Borschneck, MD principal investigator
Queen's Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing titanium rod and ultra strength stainless steel rod in people with Scoliosis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent correction in both frontal and sagittal planes for idiopathic scoliosis (time frame: pre-op, 3, 6, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.