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 fusio

Recruiting

• Conditions: Standard anterior cervical discectomy and fusion (ACDF) in patients with spine abrasion body

• Registration Number: DRKS00030844
• Lead Sponsor: Invibio Biomaterial Solutions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-13
• Last Update Posted: 19 August 2024

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 In’Oss injectable bone substitute (Biomatlante Biologics Solutions).
5.Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
6.Female subjects of childbearing age must have a negative pregnancy test, or must have a history of a surgical sterilisation, or must give history of no menses in the past twelve months.
7.Subjects who, in the opinion of the Investigator, are able to understand the nature, aims and possible consequences of the clinical study, co-operate with the procedures, and are willing to return to the clinic for all required post-operative follow-ups.
8.Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

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.
7.Subjects who are receiving any drug treatment that may affect bone metabolism.
8.Female subjects who are pregnant or lactating.
9.Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
10.Subjects who are currently enrolled in a clinical study.
11.Subjects who are currently involved in any injury litigation claims.
12.Subjects who are kept in an institution under judicial or official orders or in a residential care institution or performing mandatory military service.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the reduction (improvement) in the Neck Disability Index at 12 months post-treatment. The mean percentage reduction will be compared to a literature-based performance goal of 13% as compared to pre-treatment scores.