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NCT Number: NCT05631392

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Bg Klinikum Bergmannstrost Halle

Halle, 06112, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Neck Disability Index (NDI) Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Invibio Ltd

Industry

Collaborators

  • NGMedical GmbH

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 30, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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