This study is being conducted to evaluate the clinical and radiographic outcomes of three different interbody implant types when used with cancellous allograft chips with BMA or cellular allograft in patients undergoing XLIF surgery. The study will evaluate success by comparing the rate of fusion, complications profile, and any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate) between the three implant groups.
This study is a prospective, non-concurrent, multicenter study to compare the clinical and radiographic outcomes of smooth PEEK, 3D-printed titanium, and Porous PEEK interbody implants when used with cancellous allograft chips with BMA or cellular allograft in subjects who undergo XLIF surgery at one or two levels. To minimize selection bias, all consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo their XLIF operation using one of the 3 previously noted interbody implants based on a non-concurrent enrollment schedule. The bone graft material used inside the interbody implant will be randomly assigned between cancellous allograft chips with BMA or cellular allograft prior to surgery based on surgeon investigators' equipoise for the effectiveness of both bone graft materials. Subjects will be followed for 24 months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively.
Study Type
OBSERVATIONAL
Enrollment
300
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, United States
Lyerly Neurosurgery
Jacksonville, Florida, United States
Radiographic Fusion Success
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
Time frame: 24 months
MCID and SCB threshold for each PRO: VAS (back/leg pain), ODI, and EQ-5D, within each treatment group
Percentage of subjects meeting minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for each patient-reported outcome (PRO): Back and leg pain (visual analog scale (VAS)), disability (Oswestry disability index (ODI)), and quality of life (EQ-5D) within each treatment group.
Time frame: 3, 6, 12, and 24 months
Fusion Rates at Follow-up Timepoints
Percentage of subjects with a successful radiographic interbody fusion by each follow-up timepoint (6, 12, and 24-month postoperative follow-up)
Time frame: 6, 12, 24 months
Maintenance of Radiographic Correction
Percentage of subjects with maintenance of radiographic correction out to 24-months postoperative follow-up within each treatment group
Time frame: 3, 6, 12, and 24 months
Complications
Rate of complications attributable to the use of the interbody implants to be studied
Time frame: 3, 6, 12, and 24 months
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