Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine

N/ATerminatedNCT02068729

K2M, Inc.131 enrolled

Overview

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

131

Conditions

Degenerative Disc Disease Grade 1 Spondylolisthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Operative to 24 month

Secondary Outcomes

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 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)

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%.

Data from ClinicalTrials.gov

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