Clinical trial NCT02068729: Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
Official title: A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Grade 1 Spondylolisthesis
Keywords: degenerative disc disease
DDD
Grade 1 spondylolisthesis
spondylolisthesis
L2-S1
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Change From Baseline
timeFrame: 24 months
measure: Number of Patients With Adverse Events AEs)
timeFrame: Operative to 24 month
Secondary outcomes:
measure: Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)
timeFrame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
measure: Change in Oswestry Disability Index From Baseline (Pre-Operative)
timeFrame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
measure: Change in Health-Related Quality of Life From Baseline (Pre-op)
timeFrame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
measure: Radiographic Assessments
timeFrame: 12 mo to 24 mo
measure: Patient Satisfaction
timeFrame: 12 month and 24 month
measure: Odom's Criteria
timeFrame: 24 months
measure: Surgery Time
timeFrame: During operation.
measure: Anesthesia Time
timeFrame: During operation.
measure: Estimated Blood Loss
timeFrame: During Operation
measure: Number of Participants With Abnormal Neuromonitoring System Results
timeFrame: During operation
measure: Length of Hospital Stay
timeFrame: From admission to discharge
measure: Change in Work/School Status Compared to Baseline
timeFrame: Pre-operative to 24 months
measure: Change in Use of Narcotics Post-Surgery Compared to Baseline
timeFrame: Pre-operative to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.