A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages i… (NCT03928041) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMAâ„¢ HA Enhanced Interbody Cages in the Lumbar Spine
United States22 participantsStarted 2019-06-27
Plain-language summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is the subject aged 18 years of age or older and skeletally mature?
* Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
* Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
* Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
* Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
* Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief?
* If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months?
* Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups?
* Is the subject able to give voluntary, written informed consent…