Could a baby's birth sac help heal your neck after surgery?
NCT ID NCT04684901
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a wrap made from donated birth tissue (amniotic membrane) can reduce swelling after a two-level neck fusion surgery. About 50 adults with neck spine problems will take part. The main goal is to see if the wrap lessens soft tissue swelling one month after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of the Investigator; * Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.) or undergoing treatment for tumor or boney traumatic injury to the cervical spine or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years; * Acute cervical trauma ≤ 6 months prior to surgery; * Inflammatory disease of the cervical spine; * Has a history of substance abuse (recreational drugs, alcohol) that has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program; * Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days; * Active infection at the operative level, or a systemic infection including prior or pending treatment for HIV, Hepatitis B or Hepatitis C; * Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study; * Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation, chemotherapy or immunosuppression; * Subjects who, in the opinion of the Investigator, would not be able or willing to comply with the protocol; * Have a history of any autoimmune disease, such as, systemic lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis or rheumatoid arthritis; * Has had prior cervical spine surgery; * Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes; * Have symptomatic disease requiring fusion of one level or \> 2 levels and/or requiring fusion between levels C2-C4; * Has cervical deformity secondary to acute or chronic traumatic fracture or neoplasm, including vertebral, facet or posterior element fracture or dislocation; * Requires a concomitant posterior cervical surgery at the time of the ACDF; * Has any contraindications for MRI; * Is a ward of the state, prisoner, or transient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spine Institute of San Diego
San Diego, California, 92120, United States
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Other studies related to the condition(s) this trial covers.
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