Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervica… (NCT05631392) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion
Germany24 participantsStarted 2023-02-03
Plain-language summary
Observational data collection of information after undergoing standard Cervical spine fusion surgery.
Who can participate
Sex
ALL
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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
. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery).
. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated.
. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
Exclusion criteria
. Subjects who have undergone previous spinal surgery either anterior or posterior.
. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
. Subjects with a known allergy to the material used in the instrumentation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.