Degenerative Disc DiseaseRAVINENCT02068729
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An observational study of Degenerative Disc Disease and Grade 1 Spondylolisthesis, run by K2M, Inc..
Trial summary
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Grade 1 Spondylolisthesis
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to 28 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 eligible for study enrollment will have a primary diagnoses limited to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Qualified patients will have confirmed failure of conservative therapy as well as plain film imaging studies. Subjects must be ≥ 18 years old at the time of enrollment.
Who may be able to join
- Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1
- Inadequate response to conservative medical care over a period of at least 6 months
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature and ≥ 18 years of age at the time of enrollment
Who cannot join
- Previous anterior/posterior/lateral spine surgery at the index level
- Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis that contradicts spinal surgery
- History of an osteoporotic fracture
Show all 17Show fewer
- History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- Known allergy to titanium, cobalt chrome or PEEK
- Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
- Current medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- Pregnant, or intend to become pregnant, during the course of the study
- Severe obesity (Body Mass Index > 40)
- Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life
- Involved in current or pending spinal litigation where permanent disability benefits are being sought
- Incarcerated at the time of study enrollment
- Current participation in an investigational study that may impact study outcomes
About this study
Official title: A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
Read the detailed description
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.
- Keywords
- degenerative disc disease, DDD, Grade 1 spondylolisthesis, spondylolisthesis, L2-S1
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Change From Baseline
Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated.
VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.
Measured: 24 months
Number of Patients With Adverse Events AEs)
The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
Measured: Operative to 24 month
Secondary outcomes (13)
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)
Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)
Measured: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Change in Oswestry Disability Index From Baseline (Pre-Operative)
The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.
Measured: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Change in Health-Related Quality of Life From Baseline (Pre-op)
Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.
Measured: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Radiographic Assessments
Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include:
- Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration)
- Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging
Measured: 12 mo to 24 mo
Patient Satisfaction
At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
Measured: 12 month and 24 month
Odom's Criteria
At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows:
Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment.
Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference.
Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited.
Poor: symptoms or signs unchanged or worse.
Measured: 24 months
Surgery Time
The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.
Measured: During operation.
Anesthesia Time
The length of time the patient is under anesthesia were captured from the Anesthesia Record.
Measured: During operation.
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.
Measured: During Operation
Number of Participants With Abnormal Neuromonitoring System Results
Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.
Measured: During operation
Length of Hospital Stay
The length of hospital stay from the date of hospital admission to the date of discharge was calculated.
Measured: From admission to discharge
Change in Work/School Status Compared to Baseline
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
Measured: Pre-operative to 24 months
Change in Use of Narcotics Post-Surgery Compared to Baseline
The types and dosages of any narcotics taken by the patient post-surgery were documented.
Measured: Pre-operative to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJun 2014
- Primary completion11 Sep 2019
- Study completion28 Feb 2020
Why it stopped: The study was terminated early due to slow enrollment and difficulties with long-term follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- K2M, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068729
- Sponsor's protocol ID
- CA-002
- Acronym
- RAVINE
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2014
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Malham GM, Ellis NJ, Parker RM, Seex KA. Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.
PubMed 23213282Caputo AM, Michael KW, Chapman TM Jr, Massey GM, Howes CR, Isaacs RE, Brown CR. Clinical outcomes of extreme lateral interbody fusion in the treatment of adult degenerative scoliosis. ScientificWorldJournal. 2012;2012:680643. doi: 10.1100/2012/680643. Epub 2012 Sep 24.
PubMed 23049476Youssef JA, McAfee PC, Patty CA, Raley E, DeBauche S, Shucosky E, Chotikul L. Minimally invasive surgery: lateral approach interbody fusion: results and review. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S302-11. doi: 10.1097/BRS.0b013e3182023438.
PubMed 21160394Berjano P, Balsano M, Buric J, Petruzzi M, Lamartina C. Direct lateral access lumbar and thoracolumbar fusion: preliminary results. Eur Spine J. 2012 May;21 Suppl 1(Suppl 1):S37-42. doi: 10.1007/s00586-012-2217-z. Epub 2012 Mar 9.
PubMed 22402840
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
- ClinicalTrials.gov ID
- NCT02068729
- Acronym / sponsor ID
- RAVINE / CA-002
- Keywords
- degenerative disc disease, DDD, Grade 1 spondylolisthesis, spondylolisthesis, L2-S1
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to slow enrollment and difficulties with long-term follow-up
- Enrolment
- 131 participants (actual)
- Lead sponsor
- K2M, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
Detailed description
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for study enrollment will have a primary diagnoses limited to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Qualified patients will have confirmed failure of conservative therapy as well as plain film imaging studies. Subjects must be ≥ 18 years old at the time of enrollment.
Key inclusion criteria (5 listed)
- Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1
- Inadequate response to conservative medical care over a period of at least 6 months
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature and ≥ 18 years of age at the time of enrollment
Key exclusion criteria (17 listed)
- Previous anterior/posterior/lateral spine surgery at the index level
- Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis that contradicts spinal surgery
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
Visual Analog Scale (VAS) Change From Baseline
Time frame: 24 months
Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.
Number of Patients With Adverse Events AEs)
Time frame: Operative to 24 month
The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
13 secondary outcomes
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Change in Oswestry Disability Index From Baseline (Pre-Operative)
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Change in Health-Related Quality of Life From Baseline (Pre-op)
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Radiographic Assessments
Time frame: 12 mo to 24 mo
Patient Satisfaction
Time frame: 12 month and 24 month
Odom's Criteria
Time frame: 24 months
Surgery Time
Time frame: During operation.
Anesthesia Time
Time frame: During operation.
Estimated Blood Loss
Time frame: During Operation
Number of Participants With Abnormal Neuromonitoring System Results
Time frame: During operation
Length of Hospital Stay
Time frame: From admission to discharge
Change in Work/School Status Compared to Baseline
Time frame: Pre-operative to 24 months
Change in Use of Narcotics Post-Surgery Compared to Baseline
Time frame: Pre-operative to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23213282Malham GM, Ellis NJ, Parker RM, Seex KA. Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.
- Background: PubMed 23049476Caputo AM, Michael KW, Chapman TM Jr, Massey GM, Howes CR, Isaacs RE, Brown CR. Clinical outcomes of extreme lateral interbody fusion in the treatment of adult degenerative scoliosis. ScientificWorldJournal. 2012;2012:680643. doi: 10.1100/2012/680643. Epub 2012 Sep 24.
- Background: PubMed 21160394Youssef JA, McAfee PC, Patty CA, Raley E, DeBauche S, Shucosky E, Chotikul L. Minimally invasive surgery: lateral approach interbody fusion: results and review. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S302-11. doi: 10.1097/BRS.0b013e3182023438.
- Background: PubMed 22402840Berjano P, Balsano M, Buric J, Petruzzi M, Lamartina C. Direct lateral access lumbar and thoracolumbar fusion: preliminary results. Eur Spine J. 2012 May;21 Suppl 1(Suppl 1):S37-42. doi: 10.1007/s00586-012-2217-z. Epub 2012 Mar 9.
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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 Disc Disease and Grade 1 Spondylolisthesis, run by K2M, Inc..
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 17 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 5 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) Change From Baseline (time frame: 24 months). 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?
On the ClinicalTrials.gov record for NCT02068729, which also lists 4 linked publications.
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 5 Apr 2021.