Degenerative Disc DiseaseNCT02657421
OLIF25™ /OLIF51™ Study
An observational study of Degenerative Disc Disease and Scoliosis, run by Medtronic Spinal and Biologics at 12 sites in 7 countries.
Trial summary
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Scoliosis
- What is being tested?
- Oblique Lateral Interbody Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Nov 2015to 3 May 2018
- How long will I take part?
- 24 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
Who may be able to join
- Patient is 18 years of age or older.
- Patient agrees to participate in the study and is able to sign the informed consent/data release form.
- Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
Who cannot join
- 1. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
United States6 sites
The B.A.C.K. Center
Melbourne, Florida, 32901
Advanced Neurosurgery Associates
Murrieta, California, 92563
NewYork-Presbyterian/The Allen Hospital
New York, New York, 10034
Alleghany Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
University of California San Francisco (UCSF)
San Francisco, California, 94143
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, 33637
About this study
Official title: A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
- Conditions
- Degenerative Disc Disease, Scoliosis
- Being tested
- Oblique Lateral Interbody Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oblique Lateral Interbody FusionProcedure or surgery
Also called OLIF
The oblique lateral interbody fusion (OLIF) procedures at L2-L5 (OLIF25™) and L5-S1 (OLIF51™) is a minimally invasive surgical option for degenerative lumbar disease. This approach allows for psoas-preserving access to the lumbar spine and minimizes the need to reposition the patient during surgery for accessing additional spinal levels for the interbody fusion portion of the procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Back and Leg Pain Measured by Visual Analogue Scales (VAS)
Measured: 24 months
Oswestry Disability Index (ODI)
Measured: 24 months
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire
Measured: 24 months
Neurological deficits assessed by neurological status
Neurological status is based on seven components of measurements: Motor function; Sensory function; Deep Tendon reflexes; Sympathetic Exam; Claudication; Urinary bladder retention/Bowel retention; and Sexual Dysfunction.
Measured: 24 months
Rate of adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startNov 2015
- Primary completion3 May 2018
- Study completion3 May 2018
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657421
- Sponsor's protocol ID
- P15-05
- Status last verified
- Jul 2017
- First submitted
- 11 Jan 2016
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach
- ClinicalTrials.gov ID
- NCT02657421
- Acronym / sponsor ID
- P15-05
- Conditions
- Degenerative Disc Disease, Scoliosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 15 Jan 2016 (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 purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older.
- Patient agrees to participate in the study and is able to sign the informed consent/data release form.
- Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
Key exclusion criteria (1 listed)
- 1. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
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 |
|---|---|---|
| Oblique Lateral Interbody FusionAlso: OLIFThe oblique lateral interbody fusion (OLIF) procedures at L2-L5 (OLIF25™) and L5-S1 (OLIF51™) is a minimally invasive surgical option for degenerative lumbar disease. This approach allows for psoas-preserving access to the lumbar spine and minimizes the need to reposition the patient during surgery for accessing additional spinal levels for the interbody fusion portion of the procedure | Procedure or surgery | – |
Primary outcome
Back and Leg Pain Measured by Visual Analogue Scales (VAS)
Time frame: 24 months
Oswestry Disability Index (ODI)
Time frame: 24 months
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire
Time frame: 24 months
Neurological deficits assessed by neurological status
Time frame: 24 months
Neurological status is based on seven components of measurements: Motor function; Sensory function; Deep Tendon reflexes; Sympathetic Exam; Claudication; Urinary bladder retention/Bowel retention; and Sexual Dysfunction.
Rate of adverse events
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Scoliosis, run by Medtronic Spinal and Biologics at 12 sites in 7 countries.
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 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: stopped early, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium, Czechia, France, Italy and 2 more countries. 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.
Are results available for this study?
The study was stopped early (reason given: Business Decision). 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.
What does the primary outcome measure?
Back and Leg Pain Measured by Visual Analogue Scales (VAS) (time frame: 24 months). The study lists 5 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 4 Jun 2018.