Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures (NCT04684901) | Clinical Trial Compass
By InvitationNot Applicable
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
United States50 participantsStarted 2021-01-18
Plain-language summary
The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be a skeletally mature male or a non-pregnant, non-lactating female ≥18 years of age;
* Radiographically diagnosed with cervical stenosis or cervical disc disorder and/or degeneration, spondylolisthesis and/or cervical radiculopathy resulting from neural element compression as confirmed by MRI, CT, CT myelogram;
* Neurological dysfunction or radicular symptoms by history and physical exam;
* Is scheduled/or will be scheduled to undergo an anterior cervical fusion, requiring internal fixation using an anterior cervical standalone interbody cage system;
* Failed to gain adequate relief from non-operative treatment, including but not limited to medications, physical therapy, chiropractic care, home exercise and/or for at least 6 weeks; or the patient has progressive muscle weakness or atrophy or intractable pain;
* Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
Exclusion Criteria:
* Have a documented medical history or radiographic evidence of osteoporosis or other condition which would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving screw fixation;
* Have had or plans to have an epidural steroid injection or has taken NSAIDs ≤ 7 days prior to surgery;
* Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk based on the opinion o…