Trial Outcomes & Findings for Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (NCT NCT01511445)

Last Updated: 2017-05-08

Results Overview

The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

24 months post-op

Results posted on

2017-05-08

Participant Flow

The study was designed as double-blind randomized trial. The design called for randomizing 100 patients.

Four additional patients were randomized when four patients were excluded for protocol violations prior to the primary endpoint. A surgeon who had not been trained as an investigator operated on these four patients, making numerous protocol violations in implant technique. These patients were randomized and had pre-op data in the study.

Participant milestones

Participant milestones
Measure	ACDF With Valeo CSC Ceramic Cage ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood. Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.	ACDF With PEEK Interbody Cage Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure. Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Overall Study STARTED	53	51
Overall Study Surgeries Completed	53	51
Overall Study Primary Completion October, 2014	48	47
Overall Study Follow-up Completion	48	47
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	ACDF With Valeo CSC Ceramic Cage ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood. Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.	ACDF With PEEK Interbody Cage Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure. Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Overall Study Lost to Follow-up	3	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACDF With Valeo CSC Ceramic Cage n=53 Participants ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.	ACDF With PEEK Interbody Cage n=51 Participants Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.	Total n=104 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 9.3 • n=53 Participants	49.6 years STANDARD_DEVIATION 9.5 • n=51 Participants	51.3 years STANDARD_DEVIATION 9.5 • n=104 Participants
Sex: Female, Male Female	27 Participants n=53 Participants	25 Participants n=51 Participants	52 Participants n=104 Participants
Sex: Female, Male Male	26 Participants n=53 Participants	26 Participants n=51 Participants	52 Participants n=104 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	53 participants n=53 Participants	51 participants n=51 Participants	104 participants n=104 Participants
Use of nicotine products	23 Participants n=53 Participants	20 Participants n=51 Participants	43 Participants n=104 Participants
Symptomatic (operated) spinal level C3-C4	1 Participants n=53 Participants	1 Participants n=51 Participants	2 Participants n=104 Participants
Symptomatic (operated) spinal level C4-C5	0 Participants n=53 Participants	6 Participants n=51 Participants	6 Participants n=104 Participants
Symptomatic (operated) spinal level C5-C6	30 Participants n=53 Participants	30 Participants n=51 Participants	60 Participants n=104 Participants
Symptomatic (operated) spinal level C6-C7	20 Participants n=53 Participants	12 Participants n=51 Participants	32 Participants n=104 Participants
Symptomatic (operated) spinal level C7-T1	2 Participants n=53 Participants	2 Participants n=51 Participants	4 Participants n=104 Participants

PRIMARY outcome

Timeframe: 24 months post-op

Population: Patients who had data from 24 month follow-up visit

Outcome measures

Outcome measures
Measure	ACDF With Valeo CSC Ceramic Cage n=47 Participants ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.	ACDF With PEEK Interbody Cage n=44 Participants Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
Neck Disability Index	17.9 units on a scale from 0 to 100 Standard Deviation 14.9	16.7 units on a scale from 0 to 100 Standard Deviation 16.1

SECONDARY outcome

Timeframe: 3 mo., 6mo., 12 mo., 24 months

Population: Patients with 24 month films

Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.

Outcome measures

Outcome measures
Measure	ACDF With Valeo CSC Ceramic Cage n=43 Participants ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.	ACDF With PEEK Interbody Cage n=41 Participants Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
Fusion Status	40 Participants	37 Participants

Adverse Events

ACDF With Valeo CSC Ceramic Cage

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

ACDF With PEEK Interbody Cage

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ACDF With Valeo CSC Ceramic Cage n=53 participants at risk ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.	ACDF With PEEK Interbody Cage n=51 participants at risk Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
Musculoskeletal and connective tissue disorders Replacement of implant due to subsidence	1.9% 1/53 • Number of events 1 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team	2.0% 1/51 • Number of events 1 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team
Infections and infestations Debridement of abscess	1.9% 1/53 • Number of events 1 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team	0.00% 0/51 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team

Other adverse events

Other adverse events
Measure	ACDF With Valeo CSC Ceramic Cage n=53 participants at risk ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.	ACDF With PEEK Interbody Cage n=51 participants at risk Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
Injury, poisoning and procedural complications Dysphasia	17.0% 9/53 • Number of events 9 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team	15.7% 8/51 • Number of events 8 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team
Musculoskeletal and connective tissue disorders Surgery at additional spinal level	11.3% 6/53 • Number of events 6 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team	5.9% 3/51 • Number of events 3 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team
Immune system disorders Removal for restenosis	1.9% 1/53 • Number of events 1 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team	0.00% 0/51 Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team

Additional Information

Sonny Bal, MD

Amedica Corporation

Phone: (573) 808-4512

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place