Degeneration of Lumbar Intervertebral Disc
Conditions
Keywords
Degenerative Disc Disease, DDD, Lumbar DDD, Disc degeneration, Interbody Fusion, Lumbar Interbody Fusion, IBF
Brief summary
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition requires an interbody spinal fusion procedure combined with posterior fixation.
Detailed description
Seventy-six thousand posterior interbody fusions are performed annually in the U.S., and it has been estimated that at least 50% of those cases include supplemental posterior instrumentation. For interbody fusion with posterior fixation, spine surgeons currently place structural intervertebral spacers into the interbody space. These spacers may be pre-shaped devices constructed of allograft (cortical bone dowels or femoral rings) or non-metallic, radiolucent materials, or metallic cage devices. Autogenous bone graft and blood components (marrow, blood) are often added. Use of morselized bone graft in orthopedic procedures is desirable because it is more rapidly incorporated during the course of bone healing. If the morselized graft pack can be effectively contained in the interbody space, the graft material can function as a structural spacer to provide anterior column support. Contained graft material can be tightly packed within the mesh to increase the graft's compressive strength. Unlike pre-shaped cortical grafts, the morselized pack conforms intimately to the host bone at the surgical site, ensuring good vascularization potential and reducing the osteoblast jumping distance for osteogenesis. In addition, the solidly packed graft retains intra-pack porosity, ensuring an osteoconductive scaffold to facilitate vascular and bony ingrowth. It would be desirable to minimize autograft use because of associated post-op pain, to optimize contact between allograft and host bone, and to permit the surgeon to place or construct an effective structural intervertebral spacer with only minimal neural retraction required. OptiMesh 1500S is intended to be used to contain the bone graft placed by spine surgeons into the interbody space to achieve spinal intervertebral body fusion. OptiMesh 1500S enables the use of morselized bone graft materials in spine fusion procedures instead of solid allograft materials, such as cortical bone dowels or femoral rings, or rigid synthetic materials. In addition, the OptiMesh instrument system allows the surgeon to perform an interbody fusion through a small portal and to complete the entire fusion procedure from a posterior approach instead of a 360 degree anterior/ posterior procedure, which is often the case with the use of cages. The minimal access portal utilized for OptiMesh filling allows the device to be placed via a unilateral transforaminal or translaminar approach, versus the often-used bilateral approach required for many cages and cortical spacers. This flexibility permits the surgeon to adapt the surgical approach to the local anatomy of the patient.
Interventions
DEVICEStructural Allograft Spacer
Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
DEVICEOptiMesh 1500S
Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.
Sponsors
Spineology, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Skeletally mature and be at least 18 years of age * Have degenerative disc disease (DDD) requiring one level fusion between L2 and S1, with DDD confirmed by subject history, physical exam, and radiographic studies with one or more of the following factors: 1. instability as defined by \>3 mm translation or ≥5º rotation of flexion/ extension; 2. osteophyte formation of facet joints or vertebral endplates; 3. decreased disc height, on average 2 mm, but dependent on spinal level; 4. scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; 5. herniated nucleus pulposus; 6. facet joint degeneration/changes; and/or 7. vacuum phenomenon; * Based on the VAS, subjects report pre-operative low back pain (\>4 of 10) with duration of pain six-months or longer despite non-surgical treatment; * Capable of understanding and signing the consent form; and * Willing and able to comply with follow-up requirements
Exclusion criteria
* A previous interbody fusion at the involved level; * Greater than grade 2 spondylolisthesis; * Systemic infection or active infection at the surgical site; * Active malignancy; * Body Mass Index of 40 or higher; * Significant metabolic bone disease (e.g. osteoporosis or osteomalacia) to a degree that spinal instrumentation is contraindicated; * Taking medications that may interfere with bone or soft tissue healing (e.g. long-term steroid use); * Alcohol or drug abuse; * Waddell Signs of Inorganic Behavior \>3; * Currently in litigation regarding a spinal condition; * Known sensitivity to implant material; * A prisoner; * Pregnant or contemplating pregnancy during the 24-month follow-up period; and * Enrolled in another concurrent clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Low Back Pain Score at 24-months Compared to Pre-op | 24 month | A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of 0 represents No Pain and a score of 10 represents the Worst Possible pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op. |
| Mean Change in Back Function Score at 24-months Compared to Pre-op | 24 month | A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from 0 to 100 points. A score of 0 represents No disability and 100 represents Total disability. The magnitude of change between the two timepoints is reported. A clinically meaningful improvement is defined as a 15 point reduction at 24-months compared to the pre-op score. |
| Number of Participants Determined to be a Fusion Success at 24 Months Post-operative | 24 month | Fusion Success is defined as \<5 degrees angulation, \<10% translation, and presence of bridging bone on CT. |
| Number of Participants With a Serious Device and Procedure Related Adverse Event | From Intra-op through the 24-month visit | The rate of serious device and procedure related adverse events are compared between the control and treatment arm from intraoperative through 24 months of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Leg Pain--Change From Preop at the 24-month Timepoint | 24-month visit | Left leg pain assessed by subject response on Visual Analog Scale (0-10cm) where 0 represents No left leg pain and 10 represents Worst Pain. The magnitude of change at 24-months post-operative compared to the baseline score is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op. |
| Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative | 24-month visit | Subjects were asked to rate their satisfaction with their surgical procedure as Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied or Very Dissatisfied with their procedure |
| Right Leg Pain Score--Change From Preop at the 24-month Timepoint | 24-month visit | Right leg pain assessed by subject response on Visual Analog Scale (0-10 cm) where 0 represents No pain and 10 represents Worst pain. The magnitude of change at 24-months compared to baseline is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Optimesh 1500S OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws.
OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation. | 123 |
| Structural Allograft Spacer Structural Allograft Spacer with pedicle screws.
Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation. | 33 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 35 | 17 |
Baseline characteristics
| Characteristic | Structural Allograft Spacer | Optimesh 1500S | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 19 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 104 Participants | 133 Participants |
| Age, Continuous | 53.91 Years STANDARD_DEVIATION 10.81 | 51.18 Years STANDARD_DEVIATION 12.19 | 51.76 Years STANDARD_DEVIATION 11.93 |
| Region of Enrollment United States | 33 participants | 123 participants | 156 participants |
| Sex: Female, Male Female | 15 Participants | 57 Participants | 72 Participants |
| Sex: Female, Male Male | 18 Participants | 66 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 123 | 0 / 33 |
| other Total, other adverse events | 19 / 123 | 6 / 33 |
| serious Total, serious adverse events | 14 / 123 | 6 / 33 |
Outcome results
Primary
Mean Change in Back Function Score at 24-months Compared to Pre-op
A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from 0 to 100 points. A score of 0 represents No disability and 100 represents Total disability. The magnitude of change between the two timepoints is reported. A clinically meaningful improvement is defined as a 15 point reduction at 24-months compared to the pre-op score.
Time frame: 24 month
Population: A total of 88 investigational and 16 control subjects completed the ODI questionnaire at the 24-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optimesh 1500S | Mean Change in Back Function Score at 24-months Compared to Pre-op | -21.6 score on a scale | Standard Error 4.4055 |
| Structural Allograft Spacer | Mean Change in Back Function Score at 24-months Compared to Pre-op | -18.4 score on a scale | Standard Error 9.8028 |
Primary
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op
A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of 0 represents No Pain and a score of 10 represents the Worst Possible pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op.
Time frame: 24 month
Population: A total of 88 investigational and 16 control subjects completed this question at the 24-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optimesh 1500S | Mean Change in Low Back Pain Score at 24-months Compared to Pre-op | -4.0 units on a scale | Standard Error 0.57825 |
| Structural Allograft Spacer | Mean Change in Low Back Pain Score at 24-months Compared to Pre-op | -4.0 units on a scale | Standard Error 1.50207 |
Primary
Number of Participants Determined to be a Fusion Success at 24 Months Post-operative
Fusion Success is defined as \<5 degrees angulation, \<10% translation, and presence of bridging bone on CT.
Time frame: 24 month
Population: A total of 77 investigational and 10 control subjects achieved the required imaging (x-rays and CT scan) at the 24-month timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optimesh 1500S | Number of Participants Determined to be a Fusion Success at 24 Months Post-operative | 71 Participants |
| Structural Allograft Spacer | Number of Participants Determined to be a Fusion Success at 24 Months Post-operative | 10 Participants |
Primary
Number of Participants With a Serious Device and Procedure Related Adverse Event
The rate of serious device and procedure related adverse events are compared between the control and treatment arm from intraoperative through 24 months of follow-up.
Time frame: From Intra-op through the 24-month visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optimesh 1500S | Number of Participants With a Serious Device and Procedure Related Adverse Event | 14 Participants |
| Structural Allograft Spacer | Number of Participants With a Serious Device and Procedure Related Adverse Event | 6 Participants |
Secondary
Left Leg Pain--Change From Preop at the 24-month Timepoint
Left leg pain assessed by subject response on Visual Analog Scale (0-10cm) where 0 represents No left leg pain and 10 represents Worst Pain. The magnitude of change at 24-months post-operative compared to the baseline score is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.
Time frame: 24-month visit
Population: A total of 82 investigational subjects and 16 control subjects reported left leg pain scores at both pre-op and 24-months postoperative.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optimesh 1500S | Left Leg Pain--Change From Preop at the 24-month Timepoint | -2.5 units on a scale | Standard Error 0.4 |
| Structural Allograft Spacer | Left Leg Pain--Change From Preop at the 24-month Timepoint | -2.5 units on a scale | Standard Error 0.8 |
Secondary
Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative
Subjects were asked to rate their satisfaction with their surgical procedure as Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied or Very Dissatisfied with their procedure
Time frame: 24-month visit
Population: Patient satisfaction was not obtained in the early portion of this study. Therefore, a total of 39 investigational subjects and 16 control subjects that were enrolled in the latter portion of the study contributed responses to this question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Optimesh 1500S | Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative | 37 Participants |
| Structural Allograft Spacer | Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative | 13 Participants |
Secondary
Right Leg Pain Score--Change From Preop at the 24-month Timepoint
Right leg pain assessed by subject response on Visual Analog Scale (0-10 cm) where 0 represents No pain and 10 represents Worst pain. The magnitude of change at 24-months compared to baseline is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.
Time frame: 24-month visit
Population: A total of 78 investigational subjects and 16 control subjects reported right leg pain scores at pre-op and 24-months postoperative.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optimesh 1500S | Right Leg Pain Score--Change From Preop at the 24-month Timepoint | -2.6 units on a scale | Standard Error 0.4 |
| Structural Allograft Spacer | Right Leg Pain Score--Change From Preop at the 24-month Timepoint | -2.0 units on a scale | Standard Error 0.6 |