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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left cage- auto bone | Experimental | 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. |
|
| Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transforaminal lumbar interbody arthrodesis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwang Sup Song, M.D., PhD | Chung-Ang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwang Sup Song | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16690382 | Background | Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgical approach to the management of patients with cervical radiculopathy: a prospective observational cohort study. J Manipulative Physiol Ther. 2006 May;29(4):279-87. doi: 10.1016/j.jmpt.2006.03.005. | |
| 13539086 | Background | SMITH GW, ROBINSON RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958 Jun;40-A(3):607-24. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants - Single Group | 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 in "same segment". We compared the anterior bone bridging patterns of two cages "at single operated segment" in each patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 12 month postoperatively |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Left Cage- Auto Bone | 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. At the operated segment, left cage was filled with auto bone only. |
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Suggested criterios can only be used for interbody fusion evaluation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kwang-Sup Song | Chung-Ang University hospital | +82-1037616503 | ksong70@cau.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2021 | Jul 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D004194 | Disease |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D017886 | Durapatite |
| ID | Term |
|---|---|
| D006882 | Hydroxyapatites |
| D001031 | Apatites |
| D002130 | Calcium Phosphates |
| D010710 | Phosphates |
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|
|
| postoperative 1 year |
| 13599052 | Background | CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. doi: 10.3171/jns.1958.15.6.0602. No abstract available. |
| 9171175 | Background | Coric D, Branch CL Jr, Jenkins JD. Revision of anterior cervical pseudoarthrosis with anterior allograft fusion and plating. J Neurosurg. 1997 Jun;86(6):969-74. doi: 10.3171/jns.1997.86.6.0969. |
| 9657188 | Background | Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032. |
| 8592216 | Background | Shapiro S. Banked fibula and the locking anterior cervical plate in anterior cervical fusions following cervical discectomy. J Neurosurg. 1996 Feb;84(2):161-5. doi: 10.3171/jns.1996.84.2.0161. |
| 10647159 | Background | Wang JC, McDonough PW, Endow KK, Delamarter RB. Increased fusion rates with cervical plating for two-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2000 Jan;25(1):41-5. doi: 10.1097/00007632-200001010-00009. |
| 9765038 | Background | Zoega B, Karrholm J, Lind B. Plate fixation adds stability to two-level anterior fusion in the cervical spine: a randomized study using radiostereometry. Eur Spine J. 1998;7(4):302-7. doi: 10.1007/s005860050079. |
| 10550654 | Background | Abd-Alrahman N, Dokmak AS, Abou-Madawi A. Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Acta Neurochir (Wien). 1999;141(10):1089-92. doi: 10.1007/s007010050487. |
| 8545714 | Background | An HS, Simpson JM, Glover JM, Stephany J. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. Spine (Phila Pa 1976). 1995 Oct 15;20(20):2211-6. |
| 8755747 | Background | Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996 Aug;85(2):206-10. doi: 10.3171/jns.1996.85.2.0206. |
| 9474724 | Background | Cauthen JC, Kinard RE, Vogler JB, Jackson DE, DePaz OB, Hunter OL, Wasserburger LB, Williams VM. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998 Jan 15;23(2):188-92. doi: 10.1097/00007632-199801150-00008. |
| 9580959 | Background | Geisler FH, Caspar W, Pitzen T, Johnson TA. Reoperation in patients after anterior cervical plate stabilization in degenerative disease. Spine (Phila Pa 1976). 1998 Apr 15;23(8):911-20. doi: 10.1097/00007632-199804150-00013. |
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| 10908933 | Background | Lofgren H, Johannsson V, Olsson T, Ryd L, Levander B. Rigid fusion after cloward operation for cervical disc disease using autograft, allograft, or xenograft: a randomized study with radiostereometric and clinical follow-up assessment. Spine (Phila Pa 1976). 2000 Aug 1;25(15):1908-16. doi: 10.1097/00007632-200008010-00008. |
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| 3387340 | Background | Bagby GW. Arthrodesis by the distraction-compression method using a stainless steel implant. Orthopedics. 1988 Jun;11(6):931-4. doi: 10.3928/0147-7447-19880601-13. |
| 6367560 | Background | DeBowes RM, Grant BD, Bagby GW, Gallina AM, Sande RD, Ratzlaff MH. Cervical vertebral interbody fusion in the horse: a comparative study of bovine xenografts and autografts supported by stainless steel baskets. Am J Vet Res. 1984 Jan;45(1):191-9. |
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| 16115677 | Background | Toth JM, Wang M, Estes BT, Scifert JL, Seim HB 3rd, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006 Jan;27(3):324-34. doi: 10.1016/j.biomaterials.2005.07.011. Epub 2005 Aug 22. |
| 17686513 | Background | Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Nov;28(32):4845-69. doi: 10.1016/j.biomaterials.2007.07.013. Epub 2007 Aug 7. |
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| 15936361 | Background | Cho DY, Lee WY, Sheu PC, Chen CC. Cage containing a biphasic calcium phosphate ceramic (Triosite) for the treatment of cervical spondylosis. Surg Neurol. 2005 Jun;63(6):497-503; discussion 503-4. doi: 10.1016/j.surneu.2004.10.016. |
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| 17321970 | Background | Kulkarni AG, Hee HT, Wong HK. Solis cage (PEEK) for anterior cervical fusion: preliminary radiological results with emphasis on fusion and subsidence. Spine J. 2007 Mar-Apr;7(2):205-9. doi: 10.1016/j.spinee.2006.03.002. Epub 2006 Nov 17. |
| 12445338 | Background | Cho DY, Liau WR, Lee WY, Liu JT, Chiu CL, Sheu PC. Preliminary experience using a polyetheretherketone (PEEK) cage in the treatment of cervical disc disease. Neurosurgery. 2002 Dec;51(6):1343-49; discussion 1349-50. |
| 15993115 | Background | Kandziora F, Pflugmacher R, Scholz M, Schnake K, Putzier M, Khodadadyan-Klostermann C, Haas NP. Treatment of traumatic cervical spine instability with interbody fusion cages: a prospective controlled study with a 2-year follow-up. Injury. 2005 Jul;36 Suppl 2:B27-35. doi: 10.1016/j.injury.2005.06.012. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| body mass index | Mean | Inter-Quartile Range | kg/m^2 |
|
| OG001 | Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | 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. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | number of anterior holes | 12 month postoperatively |
|
|
|
| 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. | Of the total 65 patients, 56 were classified as having interbody fusion, and 9 were classified as not having interbody fusion. | Posted | Mean | 95% Confidence Interval | score on a scale | postoperative 1 year |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite | 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. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D009140 | Musculoskeletal Diseases |
| D010756 |
| Phosphoric Acids |
| D017976 | Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D008903 | Minerals |
| D017553 | Phosphorus Compounds |