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NCT05631392
Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion
Conditions: Cervical Disc Degeneration
Sex: All
Enrollment: 51
Sponsor: Invibio Ltd
Summary
Observational data collection of information after undergoing standard Cervical spine fusion surgery.
Eligibility Criteria
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.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.
Source: ClinicalTrials.gov (NCT05631392). StuddyBuddy aggregates publicly available trial information.