Lumbar Degenerative Disc Disease Clinical Trial
Official title:
A Prospective Non-current Concurrent Controlled Evaluation of Open and MAS® PLIF for the Treatment of Symptomatic Lumbar Degenerative Conditions
Verified date | April 2015 |
Source | NuVasive |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
Status | Completed |
Enrollment | 67 |
Est. completion date | September 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study: 1. Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1; 2. 18+ years of age at the date of written informed consent; 3. Able to undergo surgery based on physical exam, medical history and surgeon judgment; 4. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol; 5. Signed and dated informed consent form. Exclusion Criteria: - Subjects presenting with any of the following will not be included in this observational study: 1. Mental or physical condition that would limit the ability to comply with study requirements; 2. Spine abnormality requiring treatment at more than two levels; 3. Prior surgery at operative or adjacent level(s); 4. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested); 5. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease); 6. Participating in another clinical study that would confound study data. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Kuether Brain and Spine | Greensboro | North Carolina |
United States | Nova Neurosurgical Brain and Spine | Greensboro | North Carolina |
United States | Scott and White Healthcare | Temple | Texas |
United States | WellSpan Orthopedics-York | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
NuVasive |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complications | All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison. | 6-weeks | Yes |
Secondary | Clinical Outcomes | Visual analog scale (for patient self assessment of back/leg pain) | 6-weeks | No |
Secondary | Radiographic Outcomes | Radiographic assessment (AP/lateral x-rays) | 6-weeks | No |
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