Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01615328
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 4

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Intervertebral Disk Degeneration; Intervertebral Disk Displacement; Ossification of Posterior Longitudinal Ligament	Device: Cervios ChronOs; Device: Bonion	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cervios ChronOs 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 Cervios ChronOs after randomization procedure.
Experimental: Bonion 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 Bonion after randomization procedure.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin Sup Yeom, MD, PhD, Seoul National Univerity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin S. Yeom, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01615328
• Other Study ID Numbers: Bonion ACDF
• First Posted: Jun 8, 2012
• Last Update Posted: Jul 23, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Jin S. Yeom, Associate Professor, Seoul National University Hospital: anterior cervical discectomy and fusion; bone graft substitute; PEEK cage; hydroxyapatite; demineralized bone matrix; b-tricalcium phosphate; Bonion; Cervios ChronOs
• Additional relevant MeSH terms: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Ossification of Posterior Longitudinal Ligament

Study Results

Participant Flow

Arm/Group Title	Cervios ChronOS	Bonion
Arm/Group Description	The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.	The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
Period Title: Overall Study
STARTED	42	43
COMPLETED	39	38
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Cervios ChronOS	Bonion	Total
Arm/Group Description	The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.	The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.	Total of all reporting groups
Overall Participants	39	38	77
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 84.6%	31 81.6%	64 83.1%
>=65 years	6 15.4%	7 18.4%	13 16.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.3 (12.4)	51.9 (11.7)	51.6 (11.7)
Sex: Female, Male (Count of Participants)
Female	13 33.3%	13 34.2%	26 33.8%
Male	26 66.7%	25 65.8%	51 66.2%
Region of Enrollment (participants) [Number]
Korea, Republic of	39 100%	38 100%	77 100%

Outcome Measures

1. Primary Outcome

Title	Bone Fusion With CT(Postoperative 6 Months)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervios ChronOS	Bonion
Arm/Group Description	The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.	The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
Measure Participants	39	38
Number [participants]	26 66.7%	28 73.7%

2. Secondary Outcome

Title	VAS of Radiating Pain (Postoperative 6 Months)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervios ChronOs	Bonion
Arm/Group Description	The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.	The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM. Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure.
Measure Participants	39	38
Mean (Standard Deviation) [scores on a scale]	2.4 (2.3)	2.9 (2.5)

3. Secondary Outcome

Title	VAS of Neck Pain(Postoperative 6 Months)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervios ChronOs	Bonion
Arm/Group Description	The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure.	The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM. Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure.
Measure Participants	39	38
Mean (Standard Deviation) [scores on a scale]	2.3 (2.4)	2.0 (2.4)

Adverse Events

Arm/Group Title	Cervios ChronOS		Bonion
Arm/Group Description	The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.		The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
All Cause Mortality
	Cervios ChronOS		Bonion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cervios ChronOS		Bonion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Cervios ChronOS		Bonion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/38 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.