An interventional study of transforaminal lumbar interbody arthrodesis in Stenosis and Fusion of Spine (Disease), sponsored by Zenoss Co, Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by Zenoss Co, Ltd · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Zenoss Co, Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.
Procedure: transforaminal lumbar interbody arthrodesis
At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.
Procedure: transforaminal 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.
Also known as: β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss), Auto-local bone
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
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
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
| Milestone | All Study Participants - Single Group |
|---|---|
| Started | 69 |
| Completed | 65 |
| Not completed | 4 |
| Withdrew: Dropped out because they failed to undergo ct scan at postoperative 12 months | 4 |
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).
| score on a scale | Left Cage- Auto Bone | Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite |
|---|---|---|
| InCBB of Both Cages | 1.48 (1.44 to 1.53) | 1.43 (1.39 to 1.48) |
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.
| number of anterior holes | Left Cage- Auto Bonegroup | Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite |
|---|---|---|
| ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | 1.80 (1.68 to 1.92) | 1.85 (1.72 to 1.97) |
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.
| score on a scale | Interbody Fused Group | Interbody Unfused Group |
|---|---|---|
| ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) | 45.53 (43.29 to 47.90) | 35.19 (32.92 to 37.40) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Left Cage- Auto Bone | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
69 patients were enrolled. Out of the total study participants, 4 patients dropped out because they failed to undergo CT scan at postoperative 12 months.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 66.7 (65.7 to 67.7) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 45 |
| Male | 24 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| South Korea | 65 |
| body mass index(kg/m^2) | All Study Participants |
|---|---|
| Mean | 25.3 (24.3 to 26.3) |
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