Degenerative Disc DiseaseNCT03726190
Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Tristate Brain and Spine Institute at 1 site in United States.
Trial summary
This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Lumbar Disc Herniation
- What is being tested?
- Oblique Lateral Lumbar Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who presented to the study center and required lumbar fusion were eligible to participate in this study. The study center draws patients from Minnesota, South Dakota and North Dakota. No demographic restrictions were placed on participation in the study.
Who may be able to join
- Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation
- Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.
Who cannot join
- bony obstruction of the approach
- significant spinal canal stenosis
- large facet hypertrophy
- grade II listhesis
- scoliosis with Cobb angle > 10º
- Patients who underwent procedures that were converted to open fusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Tristate Brain and Spine Institute
Alexandria, Minnesota, 56308
About this study
This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.
- Being tested
- Oblique Lateral Lumbar Fusion
- Keywords
- Degenerative Disk Disease, Lumbar Fusion, Minimally Invasive Surgery, Lumbar Disk Disease
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oblique Lateral Lumbar FusionProcedure or surgery
Oblique lateral lumbar interbody fusion (OLLIF) is a lumbar spinal fusion. OLLIF is performed with the patient in the prone position and employs an oblique lateral approach that enables the instrumentation to pass through Kambin's triangle which is defined as the space between the exiting nerve, the superior border of the caudal vertebra, and the superior articulating process of the inferior facet. This approach may be performed without direct visualization, guided by electrophysiological monitoring and biplanar fluoroscopy. During the approach, a blunt probe is used to make contact with the disc, followed by a series of gentle dilations. Discectomy is performed through a 10-mm access portal. The cage is inserted under continued electrophysiological monitoring and fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| OLLIF | Patients who underwent Oblique Lateral Lumbar Interbody Fusion Receives: Procedure: Oblique Lateral Lumbar Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported disability on the Oswestry Disability Index
The Oswestry Disability Index is a commonly used tool to assess disability due to low back pain. The Oswestry is assessed on a standardized questionnaire and the scale ranges from 0% to 100% disability. A lower score is considered less disability.
Measured: One year after surgery
Fusion rate
The rate of bony fusion as determined by independent radiologists on post-operative CT scans. Radiologists will determine whether each level that was operated on was fused, or not fused.
Measured: One year after surgery
Rate of Neuropraxia
Neuropraxia is defined as lower extremity weakness of 3/5 or below on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
Measured: One year after surgery
Rate of Nerve Root Irritation
Nerve Root Irritation is defined as lower extremity paresthesias or dysesthesias corresponding to dermatome of the level of surgery or weakness of 4/5 or above on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
Measured: One year after surgery
Secondary outcomes (8)
Surgery Time
Skin to skin surgery time measured in minutes
Measured: During surgery
Hospital stay
The number of nights spent in the hospital following the surgery measured in days
Measured: Immediately after surgery
Blood Loss
The amount of blood lost during the surgery measured in milliliters.
Measured: During surgery
Fluoroscopy Time
The time fluoroscopy was used during surgery measured in seconds.
Measured: During surgery.
Rate of screw fracture
The percentage of all screws placed in the study group that is determined to have fractured on postoperative imaging. Imaging is read by independent radiologists.
Measured: One year after surgery
Infection Rate
The percentage of patients that experienced a postoperative surgical site infection.
Measured: Immediately after surgery
Bleeding Rate
The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion.
Measured: During surgery and immediately after surgery
Patient reported pain on a 10-point pain scale
The level of pain reported by the patient on a standard 10-point pain scale. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Jan 2013
- Primary completion31 Jul 2016
- Study completion31 Dec 2025 (estimated)
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
- Retrospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tristate Brain and Spine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726190
- Sponsor's protocol ID
- 201801
- Status last verified
- Mar 2021
- First submitted
- 27 Oct 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP data will not be made publicly available to preserve the privacy of study participants. Requests to access our data will be considered on a case by case basis to ensure that data cannot be re-identified.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03726190
- Acronym / sponsor ID
- 201801
- Keywords
- Degenerative Disk Disease, Lumbar Fusion, Minimally Invasive Surgery, Lumbar Disk Disease
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Tristate Brain and Spine InstituteUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Oct 2018 (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.
This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLLIF | – | Procedure: Oblique Lateral Lumbar FusionPatients who underwent Oblique Lateral Lumbar Interbody Fusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who presented to the study center and required lumbar fusion were eligible to participate in this study. The study center draws patients from Minnesota, South Dakota and North Dakota. No demographic restrictions were placed on participation in the study.
Key inclusion criteria (2 listed)
- Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation
- Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.
Key exclusion criteria (6 listed)
- bony obstruction of the approach
- significant spinal canal stenosis
- large facet hypertrophy
- grade II listhesis
- scoliosis with Cobb angle > 10º
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 Lumbar FusionOblique lateral lumbar interbody fusion (OLLIF) is a lumbar spinal fusion. OLLIF is performed with the patient in the prone position and employs an oblique lateral approach that enables the instrumentation to pass through Kambin's triangle which is defined as the space between the exiting nerve, the superior border of the caudal vertebra, and the superior articulating process of the inferior facet. This approach may be performed without direct visualization, guided by electrophysiological monitoring and biplanar fluoroscopy. During the approach, a blunt probe is used to make contact with the disc, followed by a series of gentle dilations. Discectomy is performed through a 10-mm access portal. The cage is inserted under continued electrophysiological monitoring and fluoroscopy. | Procedure or surgery | OLLIF |
Primary outcome
Patient reported disability on the Oswestry Disability Index
Time frame: One year after surgery
The Oswestry Disability Index is a commonly used tool to assess disability due to low back pain. The Oswestry is assessed on a standardized questionnaire and the scale ranges from 0% to 100% disability. A lower score is considered less disability.
Fusion rate
Time frame: One year after surgery
The rate of bony fusion as determined by independent radiologists on post-operative CT scans. Radiologists will determine whether each level that was operated on was fused, or not fused.
Rate of Neuropraxia
Time frame: One year after surgery
Neuropraxia is defined as lower extremity weakness of 3/5 or below on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
Rate of Nerve Root Irritation
Time frame: One year after surgery
Nerve Root Irritation is defined as lower extremity paresthesias or dysesthesias corresponding to dermatome of the level of surgery or weakness of 4/5 or above on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
8 secondary outcomes
Surgery Time
Time frame: During surgery
Hospital stay
Time frame: Immediately after surgery
Blood Loss
Time frame: During surgery
Fluoroscopy Time
Time frame: During surgery.
Rate of screw fracture
Time frame: One year after surgery
Infection Rate
Time frame: Immediately after surgery
Bleeding Rate
Time frame: During surgery and immediately after surgery
Patient reported pain on a 10-point pain scale
Time frame: One year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No. IDP data will not be made publicly available to preserve the privacy of study participants. Requests to access our data will be considered on a case by case basis to ensure that data cannot be re-identified.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Tristate Brain and Spine Institute at 1 site in United States.
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 2 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: paused, as of the sponsor's last update on 15 Mar 2021. 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 United States. 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?
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?
Patient reported disability on the Oswestry Disability Index (time frame: One year after surgery). The study lists 4 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 15 Mar 2021.