A Phase 4 interventional study of Cervios ChronOs and Bonion in Intervertebral Disk Degeneration, Intervertebral Disk Displacement and Ossification of Posterior Longitudinal Ligament, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-23.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 85 is above the median of 60 across 268 interventional studies indexed under Intervertebral Disc Degeneration.
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Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Device: Cervios ChronOs
The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.
Device: Bonion
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
The ACDF surgery will be carried out with Bonion after randomization procedure.
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).
Time frame: 6 months after surgery(ACDF)
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.
Time frame: at 6 months after surgery (ACDF)
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.
Time frame: at 6 months after surgery (ACDF)
| Milestone | Cervios ChronOS | Bonion |
|---|---|---|
| Started | 42 | 43 |
| Completed | 39 | 38 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 3 | 5 |
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).
| participants | Cervios ChronOS | Bonion |
|---|---|---|
| Bone Fusion With CT(Postoperative 6 Months) | 26 | 28 |
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.
| scores on a scale | Cervios ChronOs | Bonion |
|---|---|---|
| VAS of Radiating Pain (Postoperative 6 Months) | 2.4 ± 2.3 | 2.9 ± 2.5 |
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.
| scores on a scale | Cervios ChronOs | Bonion |
|---|---|---|
| VAS of Neck Pain(Postoperative 6 Months) | 2.3 ± 2.4 | 2.0 ± 2.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervios ChronOS | — | 0/39 (0%) | 0/39 (0%) |
| Bonion | — | 0/38 (0%) | 0/38 (0%) |
| Age, Categorical(Participants) | Cervios ChronOS | Bonion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 33 | 31 | 64 |
| >=65 years | 6 | 7 | 13 |
| Age, Continuous(years) | Cervios ChronOS | Bonion | Total |
|---|---|---|---|
| Mean | 51.3 ± 12.4 | 51.9 ± 11.7 | 51.6 ± 11.7 |
| Sex: Female, Male(Participants) | Cervios ChronOS | Bonion | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 26 | 25 | 51 |
| Region of Enrollment(participants) | Cervios ChronOS | Bonion | Total |
|---|---|---|---|
| Korea, Republic of | 39 | 38 | 77 |
The record gives a start of Nov 2011, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 3 months after primary completion.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
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