Intervertebral Disk Degeneration, Intervertebral Disk Displacement, Ossification of Posterior Longitudinal Ligament
Conditions
Keywords
anterior cervical discectomy and fusion, bone graft substitute, PEEK cage, hydroxyapatite, demineralized bone matrix, b-tricalcium phosphate, Bonion, Cervios ChronOs
Brief summary
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)
Detailed description
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.
Interventions
DEVICECervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
DEVICEBonion
The ACDF surgery will be carried out with Bonion after randomization procedure.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of cervical HIVD, CSR, CSM or OPLL * The patient who is expected to receive anterior cervical discectomy and fusion operation. * Volunteer for this study with written consent.
Exclusion criteria
* Patient with cervical spine fracture, infection. * Below -3.5 T-score by DEXA bone densitometry * Patient with hemorrhagic diseases * Patient with malignancy * Patient who is not suitable for this study judged by principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Fusion With CT(Postoperative 6 Months) | 6 months after surgery(ACDF) | Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS of Radiating Pain (Postoperative 6 Months) | at 6 months after surgery (ACDF) | 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. |
| VAS of Neck Pain(Postoperative 6 Months) | at 6 months after surgery (ACDF) | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervios ChronOS The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP. | 39 |
| Bonion The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix. | 38 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
Baseline characteristics
| Characteristic | Bonion | Cervios ChronOS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 33 Participants | 64 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 11.7 | 51.3 years STANDARD_DEVIATION 12.4 | 51.6 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Korea, Republic of | 38 participants | 39 participants | 77 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 |
Outcome results
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).
Time frame: 6 months after surgery(ACDF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervios ChronOS | Bone Fusion With CT(Postoperative 6 Months) | 26 participants |
| Bonion | Bone Fusion With CT(Postoperative 6 Months) | 28 participants |
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.
Time frame: at 6 months after surgery (ACDF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervios ChronOS | VAS of Neck Pain(Postoperative 6 Months) | 2.3 scores on a scale | Standard Deviation 2.4 |
| Bonion | VAS of Neck Pain(Postoperative 6 Months) | 2.0 scores on a scale | Standard Deviation 2.4 |
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.
Time frame: at 6 months after surgery (ACDF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervios ChronOS | VAS of Radiating Pain (Postoperative 6 Months) | 2.4 scores on a scale | Standard Deviation 2.3 |
| Bonion | VAS of Radiating Pain (Postoperative 6 Months) | 2.9 scores on a scale | Standard Deviation 2.5 |