Trial Outcomes & Findings for Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™ (NCT NCT01615328)
NCT ID: NCT01615328
Last Updated: 2014-07-23
Results Overview
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).
COMPLETED
PHASE4
85 participants
6 months after surgery(ACDF)
2014-07-23
Participant Flow
Participant milestones
| Measure |
Cervios ChronOS
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Cervios ChronOS
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Baseline characteristics by cohort
| Measure |
Cervios ChronOS
n=39 Participants
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
n=38 Participants
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
51.9 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
51.6 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
39 participants
n=99 Participants
|
38 participants
n=107 Participants
|
77 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Cervios ChronOS
n=39 Participants
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
n=38 Participants
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
|---|---|---|
|
Bone Fusion With CT(Postoperative 6 Months)
|
26 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cervios ChronOS
n=39 Participants
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
n=38 Participants
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
|---|---|---|
|
VAS of Radiating Pain (Postoperative 6 Months)
|
2.4 scores on a scale
Standard Deviation 2.3
|
2.9 scores on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cervios ChronOS
n=39 Participants
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
|
Bonion
n=38 Participants
The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
|
|---|---|---|
|
VAS of Neck Pain(Postoperative 6 Months)
|
2.3 scores on a scale
Standard Deviation 2.4
|
2.0 scores on a scale
Standard Deviation 2.4
|
Adverse Events
Cervios ChronOS
Bonion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jin-Sup Yeom
Seoul National University Bundang Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60