ScoliosisPhase 2NCT00273598
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
A Phase 2 study testing Moss Miami Spine Instrumentation System and Universal Spine Instrumentation System in people with Scoliosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Moss Miami Spine Instrumentation System and Universal Spine Instrumentation System
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1997to Sep 2002
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-18 years
- Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
- Patients with scoliosis and an incidental finding of conus < L1-2 disc level, provided they have no symptoms or signs
- Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
- Patients with non-progressive spondylolysis
Who cannot join
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
- Primary abnormalities of bones(e.g. osteogenesis imperfecta)
- Congenital scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.
- Conditions
- Scoliosis
- Being tested
- Moss Miami Spine Instrumentation System, Universal Spine Instrumentation System
- Keywords
- Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery
- Medical subject headings
- Scoliosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moss Miami Spine Instrumentation SystemProcedure or surgery
Universal Spine Instrumentation SystemProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
Secondary outcomes (6)
Physical function
Deformity, based on clinical exam and spinal radiographs
Clinicians' ratings of clinical photographs
Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
Surgeons' global satisfaction with the instrumentation system
Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startSep 1997
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Synthes Canada, DePuy-Acromed, Inc., Johnson & Johnson
- Responsible party
- Principal investigator, James Wright, The Hospital for Sick Children
- Investigators
- James G Wright, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273598
- Sponsor's protocol ID
- 0019970040
- Status last verified
- Oct 2017
- First submitted
- 4 Jan 2006
- Last updated
- 12 Oct 2017
- Results posted
- No
Publications
Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684-93. doi: 10.2106/JBJS.F.00720.
PubMed 18056501
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT00273598
- Acronym / sponsor ID
- 0019970040
- Conditions
- Scoliosis
- Keywords
- Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Synthes Canada, DePuy-Acromed, Inc., Johnson & Johnson
- Study start
- Sep 1997
- Study completion
- Sep 2002 (actual)
- First posted
- 9 Jan 2006 (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.
Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 8-18 years
- Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
- Patients with scoliosis and an incidental finding of conus < L1-2 disc level, provided they have no symptoms or signs
- Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
- Patients with non-progressive spondylolysis
Key exclusion criteria (6 listed)
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
- Primary abnormalities of bones(e.g. osteogenesis imperfecta)
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 |
|---|---|---|
| Moss Miami Spine Instrumentation System | Procedure or surgery | – |
| Universal Spine Instrumentation System | Procedure or surgery | – |
Primary outcome
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
6 secondary outcomes
Physical function
Deformity, based on clinical exam and spinal radiographs
Clinicians' ratings of clinical photographs
Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
Surgeons' global satisfaction with the instrumentation system
Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
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 12 Oct 2017.
- Background: PubMed 18056501Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684-93. doi: 10.2106/JBJS.F.00720.
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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.
James G Wright, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moss Miami Spine Instrumentation System and Universal Spine Instrumentation System in people with Scoliosis, run by The Hospital for Sick Children 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 5 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 12 Oct 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273598, which also lists 1 linked publication.
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 12 Oct 2017.