Degenerative Disk DiseaseNCT01045473
Prospective Study of Minimally Invasive Spine Surgery
An observational study of Degenerative Disk Disease and Spondylolisthesis, run by Society for Minimally Invasive Spine Surgery.
Trial summary
The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Degenerative Disk Disease, Spondylolisthesis, Spinal Stenosis
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2012
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthropedic surgeon's clinic. Neurosurgeon's clinic.
Who may be able to join
- Patient age 21 - 90 years.
- Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
- A spinal fusion is being undertaken via the minimally invasive approach.
- The patient agrees to follow-up for routine care for at least 2 years post-operatively.
Who cannot join
- Inability for post-operative follow-up
About this study
Official title: Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis
The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.
- Keywords
- MIS, Minimally Invasive Spine Surgery, Fusion, Spine, SMISS
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disk DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society for Minimally Invasive Spine Surgery
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045473
- Sponsor's protocol ID
- SMISS-001
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis
- ClinicalTrials.gov ID
- NCT01045473
- Acronym / sponsor ID
- SMISS-001
- Keywords
- MIS, Minimally Invasive Spine Surgery, Fusion, Spine, SMISS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Society for Minimally Invasive Spine SurgeryUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 11 Jan 2010 (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.
The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthropedic surgeon's clinic. Neurosurgeon's clinic.
Key inclusion criteria (4 listed)
- Patient age 21 - 90 years.
- Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
- A spinal fusion is being undertaken via the minimally invasive approach.
- The patient agrees to follow-up for routine care for at least 2 years post-operatively.
Key exclusion criteria (1 listed)
- Inability for post-operative 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.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disk Disease and Spondylolisthesis, run by Society for Minimally Invasive Spine Surgery.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2010. 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?
Results are not available in the source record.
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.
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 11 Jan 2010.