Symptomatic Cervical Disc Disease
Conditions
Keywords
Anterior Cervical Discectomy and Fusion,, Degenerative Disc Disease,, Cervical Spine,, Herniated Disc
Brief summary
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft or allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with allograft or autologous bone graft.
Detailed description
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft. Success criteria include radiographic evidence of fusion, and improvement in pain, function and overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion Device would eliminate complications associated with harvesting autologous bone graft and provide an alternative for those who are unable to provide autologous bone graft from the iliac crest.
Interventions
Implantation of Hedrocel
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study. * The patient has no history of previous anterior cervical fusion surgery at the involved levels. * The patient has no history of previous cervical fusion surgery at the adjacent levels. * The patient is willing and able to provide written informed consent. * The patient is likely to complete the required follow-up.
Exclusion criteria
* The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months. * The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care. * The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs. * The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis). * The patient has osteoporosis to a degree that would contraindicate spinal instrumentation. * The patient is unable or unwilling to attend postoperative follow-up visits. * The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months. * The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history. * The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously. * The patient has insufficient bone stock to fix the component. * The patient has a known sensitivity to metallic implants. * The patient is a prisoner. * The patient has a Body Mass Index (BMI) greater than or equal to 40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 12 Months | Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (\< 3mm translation; \< 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months |
| Neck Disability Index (NDI) | 12 Months | The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability. NDI scoring: * 0 - 4 = No disability * 5 - 14 = Mild disability * 15 - 24 = Moderate disability * 25 - 34 = Severe disability * 35 or over = Complete disability |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited between December 1999 and March 2007 from the investigators medical clinics.
Participants by arm
| Arm | Count |
|---|---|
| Hedrocel 1 Level Without Plate Hedrocel 1 level without plate | 14 |
| Hedrocel 1 Level With Plate Hedrocel 1 level with plate | 74 |
| Hedrocel 2 Levels With Plate Hedrocel 2 levels with plate | 53 |
| Autograft Only - Illiac Crest Autograft only - Illiac crest | 6 |
| Autograft With Plate Autograft with plate | 3 |
| Allograft With Plate Allograft with plate | 50 |
| Autograft 2 Levels With Plate Autograft 2 levels with plate | 0 |
| Allograft 2 Levels With Plate Allograft 2 levels with plate | 31 |
| Total | 231 |
Baseline characteristics
| Characteristic | Hedrocel 1 Level With Plate | Hedrocel 2 Levels With Plate | Autograft Only - Illiac Crest | Autograft With Plate | Hedrocel 1 Level Without Plate | Allograft With Plate | Allograft 2 Levels With Plate | Total |
|---|---|---|---|---|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age Categorical Between 18 and 65 years | 74 participants | 53 participants | 6 participants | 3 participants | 14 participants | 50 participants | 31 participants | 231 participants |
| Age Continuous | 44.2 years STANDARD_DEVIATION 8.6 | 49.0 years STANDARD_DEVIATION 9.94 | 47.3 years STANDARD_DEVIATION 5 | 49.0 years STANDARD_DEVIATION 4.5 | 45.14 years STANDARD_DEVIATION 9.1 | 44.1 years STANDARD_DEVIATION 6.8 | 49.29 years STANDARD_DEVIATION 8.4 | 46.86 years STANDARD_DEVIATION 7.5 |
| Gender Female | 43 participants | 28 participants | 2 participants | 0 participants | 3 participants | 25 participants | 20 participants | 121 participants |
| Gender Male | 31 participants | 25 participants | 4 participants | 3 participants | 11 participants | 25 participants | 11 participants | 110 participants |
| Region of Enrollment United States | 74 participants | 53 participants | 6 participants | 3 participants | 14 participants | 50 participants | 31 participants | 231 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 14 | 9 / 74 | 15 / 53 | 0 / 6 | 0 / 3 | 5 / 50 | 0 / 0 | 2 / 31 |
| serious Total, serious adverse events | 2 / 14 | 2 / 74 | 1 / 53 | 0 / 6 | 0 / 3 | 0 / 50 | 0 / 0 | 1 / 31 |
Outcome results
Primary
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability. NDI scoring: * 0 - 4 = No disability * 5 - 14 = Mild disability * 15 - 24 = Moderate disability * 25 - 34 = Severe disability * 35 or over = Complete disability
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Level Hedrocel Without Plate | Neck Disability Index (NDI) | 14.82 units on a scale | Standard Deviation 14.1 |
| One Level Hedrocel With Plate | Neck Disability Index (NDI) | 11.25 units on a scale | Standard Deviation 10.3 |
| Two Levels Plated Hedrocel | Neck Disability Index (NDI) | 8.77 units on a scale | Standard Deviation 7.67 |
| Illiac Crest Autograft - no Plate | Neck Disability Index (NDI) | 6.25 units on a scale | Standard Deviation 8.02 |
| Plated Autograft | Neck Disability Index (NDI) | 1 units on a scale | Standard Deviation 0 |
| Plated Allograft | Neck Disability Index (NDI) | 8.65 units on a scale | Standard Deviation 8.56 |
| 2 Levels With Plated Allograft | Neck Disability Index (NDI) | 10 units on a scale | Standard Deviation 6.77 |
Primary
Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)
Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (\< 3mm translation; \< 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Level Hedrocel Without Plate | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 5 participants |
| One Level Hedrocel With Plate | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 33 participants |
| Two Levels Plated Hedrocel | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 28 participants |
| Illiac Crest Autograft - no Plate | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 2 participants |
| Plated Autograft | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 1 participants |
| Plated Allograft | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 22 participants |
| 2 Levels With Plated Allograft | Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) | 15 participants |