A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF (NCT01640977) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
United States67 participantsStarted 2012-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
✓. 18+ years of age at the date of written informed consent;
✓. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
✓. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
✓. Signed and dated informed consent form.
Exclusion criteria
✕. Mental or physical condition that would limit the ability to comply with study requirements;
✕. Spine abnormality requiring treatment at more than two levels;
✕. Prior surgery at operative or adjacent level(s);
✕. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
✕. Participating in another clinical study that would confound study data.