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Recruiting NCT05631392

Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion

Trial Parameters

Condition Cervical Disc Degeneration
Sponsor Invibio Ltd
Study Type OBSERVATIONAL
Phase N/A
Enrollment 51
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2023-02-03
Completion 2027-06

Brief Summary

Observational data collection of information after undergoing standard Cervical spine fusion surgery.

Eligibility Criteria

Inclusion Criteria: 1. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature. 2. 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). 3. 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. 4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH). 5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief. Exclusion Criteria: 1. Su

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