Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine

Terminated

Conditions: Degenerative Disc Disease
Grade 1 Spondylolisthesis

Registration Number: NCT02068729

Lead Sponsor: K2M, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 131

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events AEs)	Operative to 24 month	The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
Visual Analog Scale (VAS) Change From Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in Use of Narcotics Post-Surgery Compared to Baseline	Pre-operative to 24 months	The types and dosages of any narcotics taken by the patient post-surgery were documented.
Radiographic Assessments	12 mo to 24 mo	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
Anesthesia Time	During operation.	The length of time the patient is under anesthesia were captured from the Anesthesia Record.
Patient Satisfaction	12 month and 24 month	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).
Change in Work/School Status Compared to Baseline	Pre-operative to 24 months	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.
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)	time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months	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)
Change in Health-Related Quality of Life From Baseline (Pre-op)	time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months	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.
Change in Oswestry Disability Index From Baseline (Pre-Operative)	time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months	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%.
Odom's Criteria	24 months	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.
Surgery Time	During operation.	The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.
Estimated Blood Loss	During Operation	The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.
Number of Participants With Abnormal Neuromonitoring System Results	During operation	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.
Length of Hospital Stay	From admission to discharge	The length of hospital stay from the date of hospital admission to the date of discharge was calculated.