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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by K2M, Inc.
Sponsor:
Information provided by (Responsible Party):
K2M, Inc.
ClinicalTrials.gov Identifier:
NCT02068729
First received: February 11, 2014
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Phase
Degenerative Disc Disease
Grade 1 Spondylolisthesis.
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®

Further study details as provided by K2M, Inc.:

Primary Outcome Measures:
  • Back and Leg Visual Analog Scale (VAS) Change from Baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluation of the improvement of the Back 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 will be captured and evaluated.

  • Number of Patients with Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The evaluation of all adverse events including device related, procedure related and additional serious adverse events.


Secondary Outcome Measures:
  • Change in Incidence of Thigh Pain/Dysesthesia [ Time Frame: Baseline, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    An independent 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 will be performed.

  • Change in Oswestry Disability Index [ Time Frame: Baseline, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    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). Each item is scored from 0 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%. An improvement by at least 15 percentage points will be considered a success.

  • Change in Health-Related Quality of Life from Baseline [ Time Frame: Baseline, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    Health-related quality of life will be 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 will be evaluated against published normative values and a 15% improvement in these scores will be used as an assessment of success. To calculate the true value of a treatment, the scores from the SF-12v2 will be converted into a utility index (SF-6D), which considers not only how many years a medical intervention can add to a patient's life, but also the quality of that life. Use of the SF-6D does not expand the questions administered to the patient.

  • Radiographic Assessments [ Time Frame: AP & Lateral: pre-operatively, 6 months post-operatively, 12 months post-operatively, 24 months post-operatively; Flexion/Extension:12 months post-operatively, 24 months post-operatively ] [ Designated as safety issue: No ]

    Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images will be performed. Radiographic assessments being performed include:

    • Qualitative Assessment
    • Device Condition
    • Device Subsidence
    • Device Migration
    • Radiographic Assessment of Fusion/Non-fusion
    • Bony Bridging
    • Radiolucency
    • Development of Pseudoarthrosis

  • Patient Satisfaction [ Time Frame: 12 month and 24 month follow-up visits ] [ Designated as safety issue: No ]
    At the 12 month and 24 month follow-up visits, subjects will be asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).

  • Odom's Criteria [ Time Frame: 24 months post-operatively ] [ Designated as safety issue: No ]

    At the 24 month follow-up visit, the Investigator will rate 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 [ Time Frame: During operation. ] [ Designated as safety issue: No ]
    The length of the surgical procedure from the initial incision to final closure will be captured from the Anesthesia Record.

  • Anesthesia Time [ Time Frame: During operation. ] [ Designated as safety issue: No ]
    The length of time the patient is under anesthesia will be captured from the Anesthesia Record.

  • Estimated Blood Loss [ Time Frame: During Operation ] [ Designated as safety issue: Yes ]
    The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, will be captured.

  • Neuromonitoring [ Time Frame: During operation ] [ Designated as safety issue: No ]
    The type(s) and any abnormal result(s) of neuromonitoring systems utilized during the surgery will be captured.

  • Length of Hospital Stay [ Time Frame: At discharge, estimated average of 2 days post-surgery. ] [ Designated as safety issue: No ]
    The length of hospital stay from the date of hospital admission to the date of discharge will be calculated.

  • Change in Work/School Status compared to Baseline [ Time Frame: up to 8 weeks post-operatively, 3 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented.

  • Change in Use of Narcotics Post-Surgery Compared to Baseline [ Time Frame: up to 8 weeks post-operatively, 3 months, 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
    The types and dosages of any narcotics taken by the patient post-surgery will be documented.


Estimated Enrollment: 222
Study Start Date: May 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  • Insulin-dependent type 1 or type 2 diabetes
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068729

Contacts
Contact: Julie L Reigrut, MS 3305180174 jreigrut@k2m.com
Contact: Dawn Tolbert 7038401746 dtolbert@k2m.com

Sponsors and Collaborators
K2M, Inc.
  More Information

Publications:
Responsible Party: K2M, Inc.
ClinicalTrials.gov Identifier: NCT02068729     History of Changes
Other Study ID Numbers: CA-002
Study First Received: February 11, 2014
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by K2M, Inc.:
degenerative disc disease
DDD
Grade 1 spondylolisthesis
spondylolisthesis
L2-S1

Additional relevant MeSH terms:
Spinal Diseases
Spondylolisthesis
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on August 21, 2014