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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
231
Implantation of Hedrocel
Implantation of Allograft
Implantation of Autograft
Cedars-Sinai Medical Center Institute for Spinal Disorders
Los Angeles, California, United States
Orthopaedic Specialties
Clearwater, Florida, United States
Southeastern Clinic Research
Orlando, Florida, United States
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
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
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