Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine (RAVINE)
|ClinicalTrials.gov Identifier: NCT02068729|
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2014
Last Update Posted : June 16, 2017
|Condition or disease|
|Degenerative Disc Disease Grade 1 Spondylolisthesis|
|Study Type :||Observational|
|Estimated Enrollment :||222 participants|
|Official Title:||A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2020|
- Back and Leg Visual Analog Scale (VAS) Change from Baseline [ Time Frame: 24 months ]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 ]The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
- 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 ]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 ]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 ]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 ]
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
- Development of Pseudoarthrosis
- Patient Satisfaction [ Time Frame: 12 month and 24 month follow-up visits ]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 ]
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. ]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. ]The length of time the patient is under anesthesia will be captured from the Anesthesia Record.
- Estimated Blood Loss [ Time Frame: During Operation ]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 ]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. ]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 ]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 ]The types and dosages of any narcotics taken by the patient post-surgery will be documented.