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

Recruiting

• Conditions: Cervical Disc Degeneration

• Registration Number: NCT05631392
• Lead Sponsor: Invibio Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-30
• Study Start: 2023-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI) Questionnaire	24 months	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.

Trial Locations

Locations (1)

Bg Klinikum Bergmannstrost Halle; 🇩🇪 Halle, Germany