Evaluating outcomes of a specific cervical spine fusion technique

A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.

This study looks at how well a new type of implant used in neck surgery helps people recover and feel better after their cervical spine fusion.

Quick facts

• Study type: Observational
• Enrollment: 51 (estimated)
• Sex: All
• Sponsor: Invibio Ltd (Industry-sponsored)
• Locations: 1 site (Halle)
• Trial ID: NCT05631392 on ClinicalTrials.gov

What this trial studies

This observational study collects data on clinical and radiographic outcomes following the use of the BEE® HA Cage in anterior cervical discectomy and fusion surgeries. Participants will be monitored after undergoing standard cervical spine fusion surgery to assess the effectiveness of this specific surgical intervention. The study aims to gather insights into patient recovery and overall outcomes related to cervical disc degeneration. Data will be collected from subjects who meet specific inclusion criteria regarding their cervical conditions and previous treatment attempts.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific cervical spine conditions requiring surgical intervention.

Not a fit: Patients who have not undergone conservative treatment or those with contraindications for the BEE® HA Cage may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of the BEE® HA Cage, potentially improving surgical outcomes for patients with cervical disc degeneration.

How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown promise in evaluating surgical outcomes for cervical spine interventions.

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. Subjects who have undergone previous spinal surgery either anterior or posterior.
2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
3. Subjects with a known allergy to the material used in the instrumentation.
4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.

Where this trial is running

Halle

• Bg Klinikum Bergmannstrost Halle — Halle, Germany (Recruiting)

Study contacts

• Study coordinator: Karen 2 Robson

Conditions Cervical Disc Degeneration