Fusion of Spine (Disease), Stenosis
Conditions
Keywords
Bone bridging, Arthrodesis, Lumbar, Cage
Brief summary
The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.
Detailed description
A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone. Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan. The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.
Interventions
PROCEDUREtransforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Sponsors
Zenoss Co, Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability) * Patients who have no communication problems * Patients who are willing to visit the hospital for any follow-up assessment * Patients who voluntarily sign on a written consent
Exclusion criteria
* Patients who have infection * Patients who have bleeding disorders * Patients who have immunosuppressed disease * Patients who can't sign on consent form * Patients who are in pregnancy or breast feeding * Patients who have severe osteoporosis * Patients who can't take general surgery because of severe liver disease or decreased renal function * Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| InCBB of Both Cages | 12 month postoperatively | We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | 12 month postoperatively | We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) | postoperative 1 year | The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted. We compared the anterior bone bridging patterns of two cages in each patient. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | dropped out because they failed to undergo CT scan at postoperative 12 months | 4 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 66.7 years | — |
| body mass index | 25.3 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment South Korea | 65 Participants | — |
| Sex: Female, Male Female | 45 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
Primary
InCBB of Both Cages
We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).
Time frame: 12 month postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Left Cage- Auto Bone | InCBB of Both Cages | 1.48 score on a scale |
| Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | InCBB of Both Cages | 1.43 score on a scale |
Secondary
ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone
We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient.
Time frame: 12 month postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Left Cage- Auto Bone | ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | 1.80 number of anterior holes |
| Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | 1.85 number of anterior holes |
Other Pre-specified
ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)
The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: postoperative 1 year
Population: Of the total 65 patients, 56 were classified as having interbody fusion, and 9 were classified as not having interbody fusion.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Left Cage- Auto Bone | ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) | 45.53 score on a scale |
| Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) | 35.19 score on a scale |