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| ID | Type | Description | Link |
|---|---|---|---|
| NL36103.098.11 | Registry Identifier | Netherlands Trial Registry |
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This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACDF with PEEK interbody cage | Active Comparator | 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. |
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| ACDF with Valeo CSC Ceramic Cage | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cervical discectomy and fusion (ACDF) with PEEK Cage | Device | Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer |
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| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | 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. | 24 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Status | 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. | 3 mo., 6mo., 12 mo., 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark P Arts, MD, PhD | Medical Center Haaglanden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Haaglanden | The Hague | 2501 CK | Netherlands |
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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.
The study was designed as double-blind randomized trial. The design called for randomizing 100 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ACDF With Valeo CSC Ceramic Cage | ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. |
| BG001 | ACDF With PEEK Interbody Cage | Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at date of surgery |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neck Disability Index | 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. | Patients who had data from 24 month follow-up visit | Posted | Mean | Standard Deviation | units on a scale from 0 to 100 | 24 months post-op |
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Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACDF With Valeo CSC Ceramic Cage | ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Replacement of implant due to subsidence | Musculoskeletal and connective tissue disorders | Systematic Assessment | Cage subsidence led to symptoms; revised by removing cage and replacing with bone graft and a cervical plate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphasia | Injury, poisoning and procedural complications | Systematic Assessment | Difficulty swallowing in the immediate post-op period. All cases resolved completely as post-op swelling subsided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonny Bal, MD | Amedica Corporation | (573) 808-4512 | SBal@amedica.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D013118 | Spinal Cord Diseases |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
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| Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage | Device | Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer. |
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| Protocol Violation |
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| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Use of nicotine products | Count of Participants | Participants |
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| Symptomatic (operated) spinal level | Patients were operated at a single cervical spinal level from C3-C4 to C7-T1 | Count of Participants | Participants |
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Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
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| Secondary | Fusion Status | 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. | Patients with 24 month films | Posted | Count of Participants | Participants | 3 mo., 6mo., 12 mo., 24 months |
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| 2 |
| 53 |
| 16 |
| 53 |
| EG001 | ACDF With PEEK Interbody Cage | Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. | 1 | 51 | 11 | 51 |
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| Debridement of abscess | Infections and infestations | Systematic Assessment | The abscess was cleaned in a second surgery without cage removal |
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| Surgery at additional spinal level | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery for development of new or persistent symptoms. More common at lower cervical spine levels. |
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| Removal for restenosis | Immune system disorders | Systematic Assessment | Patient had undiagnosed Becherew's disease (ankylosing spondylitis), an exclusion criterion for the study. A bone spur regrew underneath the cage. The patient had a revision with bone graft and a cervical plate. |
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| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| C5-C6 |
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| C6-C7 |
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| C7-T1 |
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