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Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these complications, some authors have tried to use alterative bone graft substitutes. Among these alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However, b-TCP has only osteoconduction ability of three osteogenic properties.
Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and osteoinduction, therefore this alternative is expected to show superior bone fusion capability to PEEK cage with b-TCP. However, there has been no comparison study between the PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate bone fusion rate between these cervical spine cages using postoperative computed tomography (CT)
Biologically, graft material should be endowed with several basic properties. Several synthetic materials and graft substitutes have been developed to maximize fusion outcomes while avoiding complications of harvesting autograft. Mixture of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), have been widely utilized for bony regeneration. On the other hand, demineralized bone matrix (DBM) has been utilized as a graft substitute with mainly its osteoinductive ability. While HA and β-TCP have osteoinductive osteoconductive properties and DBM has osteoconductive osteoinductive properties, a graft material fully incorporating both properties has not been developed. We hypothesize that an interbody graft material equipped simultaneously with osteoinductivity and osteoconductivity would enhance fusion achievement; however, clinical trials with mixture materials within a PEEK cage in ACDF surgery have rarely been performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervios ChronOs | Experimental | The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. |
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| Bonion | Experimental | The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervios ChronOs | Device | The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bone Fusion With CT(Postoperative 6 Months) | Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF). | 6 months after surgery(ACDF) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS of Radiating Pain (Postoperative 6 Months) | Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right. | at 6 months after surgery (ACDF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Sup Yeom, MD, PhD | Seoul National Univerity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervios ChronOS | The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP. |
| FG001 | Bonion | The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bonion | Device | The ACDF surgery will be carried out with Bonion after randomization procedure. |
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| VAS of Neck Pain(Postoperative 6 Months) | Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right. | at 6 months after surgery (ACDF) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervios ChronOS | The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP. |
| BG001 | Bonion | The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Bone Fusion With CT(Postoperative 6 Months) | Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF). | Posted | Number | participants | 6 months after surgery(ACDF) |
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| Secondary | VAS of Radiating Pain (Postoperative 6 Months) | Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right. | Posted | Mean | Standard Deviation | scores on a scale | at 6 months after surgery (ACDF) |
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| Secondary | VAS of Neck Pain(Postoperative 6 Months) | Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right. | Posted | Mean | Standard Deviation | scores on a scale | at 6 months after surgery (ACDF) |
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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 | Cervios ChronOS | The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP. | 0 | 39 | 0 | 39 | ||
| EG001 | Bonion | The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix. | 0 | 38 | 0 | 38 |
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Our study was included relatively small samples and short follow-up periods with 77 patients and one year duration. the measurement bias could be presented by individually different extent of neck flexion and extension in dynamic radiographs.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin-Sup Yeom | Seoul National University Bundang Hospital | 82-31-787-7190 | highcervical@gmail.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| D017887 | Ossification of Posterior Longitudinal Ligament |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009999 | Ossification, Heterotopic |
| D010335 | Pathologic Processes |
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| >=65 years |
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| Male |
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