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.

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Neck Disability Index (NDI) Questionnaire

Timeframe: 24 months

NCT IDNCT05631392

SponsorInvibio Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-06

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.