Adolescent Idiopathic ScoliosisNCT04175145
Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Ghurki Trust and Teaching Hospital.
Trial summary
A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Posterior spinal instrumentation
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Retrospective review of all patients with Adolescent Idiopathic Scoliosis patients operated at our hospital during study period
Who may be able to join
- Patients with adolescent idiopathic scoliosis
- Age more than 10 years at time of surgery
- Posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra
- A major curve magnitude between 45 and 80 degrees.
Who cannot join
- Scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis
- Previous spine surgery
- Use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws
- ALenke 5 curve
- Patients with less than 2 years' follow-up
- Use of hooks or wires below the uppermost instrumented level
About this study
Official title: Impact of Metal Density on Deformity Correction in Posterior Fusions for Adolescent Idiopathic Scoliosis
A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.
Read the detailed description
Posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (AIS). Pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. The higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. However, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. Multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. Given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability.
The rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. Furthermore, health-related quality of life instruments such as the SRS 22, 24, or 30 seem to show little correlation with curve correction. The placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. If implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. Several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. The purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Posterior spinal instrumentation
- Keywords
- Adolescent idiopathic scoliosis, posterior instrumentation, metal density, correction, Pakistan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior spinal instrumentationOther
A fusion construct consisting of all pedicle screws except at uppermost instrumented vertebra. Contoured dual 6-mm stainless steel rods were used to connect the construct. Pedicle screw location and density was determined by the surgeon based on perceived curve stiffness and fusion length with an even distribution of fixation points along the construct. Pedicle screw instrumentation was performed by the free hand technique with biplanar fluoroscopic and direct screw EMG impedance testing for confirmation of placement. Reduction was via cantilever-segmental-translation maneuver in all cases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correction achieved
(Preop Cobb angle - Postop Cobb angle/ Preop Cobb angle * 100)
Measured: 2 years
Cobb angle
Cobb angle is measured as angle sub-tented between the upper and lower end vertebrae (end vertebrae is defined as the vertebra that is most tilted from the horizontal apical vertebra)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghurki Trust and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Irfan Qadir, Principal investigator, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching HospitalProf.Amer Aziz, Professor and Chief, Study director, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching HospitalAbdullah Shah, Assistant Professor, Study chair, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching HospitalSyed Roman Alam, Resident, Study chair, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching HospitalHaseeb Hussain, Senior Registrar, Study chair, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching HospitalProf.Rizwan Akram, Professor, Study chair, Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175145
- Sponsor's protocol ID
- 19
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metal Density on Deformity Correction in Posterior Fusions for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04175145
- Acronym / sponsor ID
- 19
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, posterior instrumentation, metal density, correction, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ghurki Trust and Teaching HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Nov 2019 (actual)
- 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.
A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.
Detailed description
Posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (AIS). Pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. The higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. However, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. Multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. Given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability.
The rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. Furthermore, health-related quality of life instruments such as the SRS 22, 24, or 30 seem to show little correlation with curve correction. The placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. If implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. Several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. The purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Retrospective review of all patients with Adolescent Idiopathic Scoliosis patients operated at our hospital during study period
Key inclusion criteria (4 listed)
- Patients with adolescent idiopathic scoliosis
- Age more than 10 years at time of surgery
- Posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra
- A major curve magnitude between 45 and 80 degrees.
Key exclusion criteria (6 listed)
- Scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis
- Previous spine surgery
- Use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws
- ALenke 5 curve
- Patients with less than 2 years' follow-up
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 |
|---|---|---|
| Posterior spinal instrumentationA fusion construct consisting of all pedicle screws except at uppermost instrumented vertebra. Contoured dual 6-mm stainless steel rods were used to connect the construct. Pedicle screw location and density was determined by the surgeon based on perceived curve stiffness and fusion length with an even distribution of fixation points along the construct. Pedicle screw instrumentation was performed by the free hand technique with biplanar fluoroscopic and direct screw EMG impedance testing for confirmation of placement. Reduction was via cantilever-segmental-translation maneuver in all cases. | Other | – |
Primary outcome
Degree of correction achieved
Time frame: 2 years
(Preop Cobb angle - Postop Cobb angle/ Preop Cobb angle * 100)
Cobb angle
Time frame: 2 years
Cobb angle is measured as angle sub-tented between the upper and lower end vertebrae (end vertebrae is defined as the vertebra that is most tilted from the horizontal apical vertebra)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Dr Irfan Qadir principal investigator
Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
Prof.Amer Aziz, Professor and Chief study director
Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
Abdullah Shah, Assistant Professor study chair
Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Ghurki Trust and Teaching Hospital.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of correction achieved (time frame: 2 years). The study lists 2 primary outcomes in all. 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 22 Nov 2019.