Lumbar Degenerative Disc Disease, Lumbar Spinal Deformity, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spondylosis
Conditions
Keywords
lumbar spinal arthrodesis, interbody cage, 3D-printing
Brief summary
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM poly-ether-ether-ketone cage.
Detailed description
This randomized controlled trial will prospectively evaluate the safety and efficacy of the Nexxt MatrixxTM System titanium implant supplemented with a pedicle screw system as compared to a representative PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years post operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized). This single centered study will enroll up to 70 subjects (n = 35 per group), with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery. Subjects will be randomized in the trial to receive either the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM PEEK cage supplemented with a pedicle screw system and milled local autograft bone. Subject randomization will be stratified according to smoking status. Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively). Subject study data will be collected preoperatively, intra-operatively and postoperatively at 3, 6, 12, and 24 months.
Interventions
DEVICEInterbody cage (titanium)
Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
DEVICEInterbody cage (PEEK)
Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
Sponsors
Nexxt Spine, LLC
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded to their group status for the duration of the study assessments and procedures (up to 24 months post-operatively).
Intervention model description
All subjects will be randomized in the trial to receive either the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM PEEK cage supplemented with a pedicle screw system and milled local autograft bone. Subject randomization will be stratified according to smoking status.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Nexxt MatrixxTM 3D-printed titanium cage or HonourTM PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system. * Subject must be over the age of 18 years old. * Subject has been unresponsive to conservative care for a minimum of 6 months. * The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Exclusion criteria
* Subjects with previous lumbar arthrodesis surgery. * Subjects requiring additional bone grafting materials other than local autograft bone. * Subject has inadequate tissue coverage over the operative site. * Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis. * Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.). * Subject has an active local or systemic infection. * Subject has a metal sensitivity/foreign body sensitivity. * Subject is morbidly obese, defined as a body mass index (BMI) greater than 40. * Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. * Subject is currently involved in another investigational drug or device study that could confound study data. * Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. * Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. * Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. * Subject is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interbody Radiographic Fusion Rate | 6 months post-operatively | Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Timing of Fusion | 12 months post-operatively | Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D-printed Titanium Cage Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery. | 25 |
| Poly-ether-ether-ketone (PEEK) Cage Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. | 28 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 3D-printed Titanium Cage | Poly-ether-ether-ketone (PEEK) Cage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 22 Participants | 41 Participants |
| Current Smoker | 8 Participants | 11 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 28 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 25 Participants | 48 Participants |
| Region of Enrollment United States | 25 participants | 28 participants | 53 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 28 |
| other Total, other adverse events | 3 / 25 | 9 / 28 |
| serious Total, serious adverse events | 7 / 25 | 6 / 28 |
Outcome results
Primary
Interbody Radiographic Fusion Rate
Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.
Time frame: 6 months post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3D-printed Titanium Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 3 | 27 Cages/Spinal Levels |
| 3D-printed Titanium Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 2 | 6 Cages/Spinal Levels |
| 3D-printed Titanium Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 1 | 0 Cages/Spinal Levels |
| 3D-printed Titanium Cage | Interbody Radiographic Fusion Rate | Level with Cage Removed- Grade Not Applicable | 1 Cages/Spinal Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Interbody Radiographic Fusion Rate | Level with Cage Removed- Grade Not Applicable | 0 Cages/Spinal Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 3 | 10 Cages/Spinal Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 1 | 6 Cages/Spinal Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Interbody Radiographic Fusion Rate | Level with BSF Grade 2 | 24 Cages/Spinal Levels |
Secondary
Post-operative Timing of Fusion
Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year.
Time frame: 12 months post-operatively
Population: Overall Number of Participants and Units Analyzed relied on available imaging at one year: Flexion extension films at one year were available for 18 (69.2%) PEEK patients and 16 (66.7%) of titanium patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3D-printed Titanium Cage | Post-operative Timing of Fusion | Surgical levels over 2 degrees of change (non-union/non-fusion) | 5 Surgical Levels |
| 3D-printed Titanium Cage | Post-operative Timing of Fusion | Surgical levels under 2 degrees of change (fusion) | 19 Surgical Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Post-operative Timing of Fusion | Surgical levels over 2 degrees of change (non-union/non-fusion) | 12 Surgical Levels |
| Poly-ether-ether-ketone (PEEK) Cage | Post-operative Timing of Fusion | Surgical levels under 2 degrees of change (fusion) | 17 Surgical Levels |