Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine (RAVINE)

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease; 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 Type: Observational
• Enrollment (Actual): 131

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Operative to 24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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%.	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.	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	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).	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.	24 months
Surgery Time	The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.	During operation.
Anesthesia Time	The length of time the patient is under anesthesia were captured from the Anesthesia Record.	During operation.
Estimated Blood Loss	The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.	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.	During operation
Length of Hospital Stay	The length of hospital stay from the date of hospital admission to the date of discharge was calculated.	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.	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.	Pre-operative to 24 months

Collaborators and Investigators

• Sponsor: K2M, Inc.

Publications and helpful links

General 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.
• Caputo 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.
• Youssef 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.
• Berjano 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): September 11, 2019
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (ESTIMATE): February 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: DDD; spondylolisthesis; degenerative disc disease; Grade 1 spondylolisthesis; L2-S1
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: CA-002