A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- K2M, Inc.
- Enrollment
- 131
- Primary Endpoint
- Number of Patients With Adverse Events AEs)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)
- 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)
- Change in Use of Narcotics Post-Surgery Compared to Baseline(Pre-operative to 24 months)
- 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)
- Odom's Criteria(24 months)
- Surgery Time(During operation.)
- Estimated Blood Loss(During Operation)
- Number of Participants With Abnormal Neuromonitoring System Results(During operation)
- Length of Hospital Stay(From admission to discharge)
- Radiographic Assessments(12 mo to 24 mo)
- Anesthesia Time(During operation.)
- Patient Satisfaction(12 month and 24 month)
- Change in Work/School Status Compared to Baseline(Pre-operative to 24 months)