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

NCT05631392 | Active Not Recruiting

• 1 other identifier: NGM01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI) Questionnaire

  Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby "0" is no pain and "5" is the worse pain. Maximum score for the questionnaire of "50" is possible.

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective study so patient population taken from those undergoing cervical spine fusion surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invibio Ltd: lead
• NGMedical GmbH: collaborator

Study Sites (1)

Bg Klinikum Bergmannstrost Halle

Halle, 06112, Germany

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: February 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)