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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smooth PEEK Interbody Implants in XLIF | Smooth PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) provide maximum surface area and structural stability with large central apertures to allow bony through-growth. Multiple length options enable optimal apophyseal support, thus reducing the chance of subsidence. Additionally, lordotic profiles are available to induce proper sagittal alignment. | ||
| 3D-Printed Titanium Interbody Implants in XLIF | 3D-printed, fully porous titanium interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) have a porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding and improved radiographic imaging. The advanced microporous surface topography creates an ideal environment for bone in-growth. | ||
| Porous PEEK Interbody Implants in XLIF | Porous PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) combine the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. The Porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores, as demonstrated in preclinical studies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion Success | The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Male and female patients who are 18-80 years of age;
Planned interbody fusion surgery, including at least one level of extreme lateral interbody fusion (XLIF) prior to enrollment in the research at one or two consecutive lumbar levels for degenerative disc disease, including those with up to Grade 2 spondylolisthesis, with one of the following NuVasive, Inc. interbody implants:
If a transforaminal lumbar interbody fusion or anterior lumbar interbody fusion (TLIF or ALIF) is planned adjacent to the XLIF level, the same NuVasive, Inc. interbody implant material type must be used as determined by the implant enrollment schedule. For example:
The planned procedure must include placement of bilateral posterior screw fixation with or without intrafacet fusion using autograft (with or without the assigned allograft used at the XLIF level(s)) at the treated level(s). Direct posterior decompression at the index interbody fusion level(s) is acceptable.
Preoperative coronal Cobb angle of < 10°;
Able to undergo surgery based on physical exam, medical history, and surgeon judgment;
Understands the conditions of enrollment and willing to sign an informed consent to participate in the evaluation.
Exclusion Criteria:
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Male and female patients who are 18-80 years of age with planned extreme lateral interbody fusion (XLIF) surgery prior to enrollment in the research at one or two lumbar levels for the treatment of degenerative disc disease, including those with up to Grade 2 spondylolisthesis.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | Globus Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Bone and Joint Institute | Hartford | Connecticut | 06106 | United States | ||
| Lyerly Neurosurgery |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| 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) | 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 | 3, 6, 12, and 24 months |
| Complications | Rate of complications attributable to the use of the interbody implants to be studied | 3, 6, 12, and 24 months |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| University of South Florida Department of Neurosurgery, Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States |
| Suburban Hospital, Johns Hopkins Medicine | Bethesda | Maryland | 20814 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Columbia Orthopedic Group Research | Columbia | Missouri | 65201 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Atlantic Brain and Spine | Wilmington | North Carolina | 28401 | United States |
| The Spine Clinic of OKC | Oklahoma City | Oklahoma | 73114 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| Evergreen Health | Kirkland | Washington | 98034 | United States |
| D055009 |
| Spondylosis |