Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study (AWB) to evaluate the Transmaxx® ALIF Cage in spine surgery use according to the intended purpose.

• Conditions: M51; M43; Other intervertebral disc disorders; Other deforming dorsopathies

• Registration Number: DRKS00031819
• Lead Sponsor: Silony Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

The ability to read, understand and speak the local language fluently

- Signed informed consent and protocol-specific examinations

- The surgical indication must be one or a combination of the following.
• Degenerative disc disease
• Spondylolisthesis (up to Grade 1)

- Mono-, bi- and multisegmental treatment

- Age: = 18 years

- Surgical technique: Transmaxx® ALIF Cage und posteriore Stabilisierung

Exclusion Criteria

• Reduced bone quality (e.g. osteoporosis or bone
decalcification)
• Fractures
• Tumors
• Active infection
• Local inflammation
• Primary spinal deformities
• Allergy to titanium or its alloys
• Intraoperative circumstances necessitating implantation of an implant other than the implant type intended in the study (as determined by the surgeon)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ODI change at 12 months post-op compared to pre-op

Secondary Outcome Measures

Name	Time	Method
Investigation of clinical safety: <br>Adverse events/risks incl. classification in relation to implant. <br><br>Investigation of clinical performance:<br>Product performance in terms of fusion, height restoration, functional outcomes <br><br>Investigation of patient satisfaction: <br>Reduction in pain as measured by VAS (back and <br>leg/buttock pain)