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

Cervical Disc Degeneration Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631392
• Other study ID #: NGM01
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Invibio Ltd
• Contact: Karen 2 Robson
• Phone: 07765220492
• Email: karen.robson[@]invibio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
Germany	Bg Klinikum Bergmannstrost Halle	Halle

Sponsors (2)

Lead Sponsor	Collaborator
Invibio Ltd	NGMedical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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