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.

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. - PMCF Transmaxx system

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031819

Enrollment

Registered

2023-05-30

Start date

2026-07-30

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M51 M43

Interventions

Group 1: Pre-op: - ODI - VAS back pain - VAS Leg pain - Neurological assessment - Radiological assessment Intra-OP/post-OP discharge - Recording of possible intraoperative complications - Surgery det

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
ODI change at 12 months post-op compared to pre-op	—

Secondary

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

Countries

Germany

Contacts

Public ContactRoland Rusz

Wirbelsäulenzentrum Schön Klinik Bad Aibling SE & Co. KG

Rrusz@schoen-klinik.de+49 8061 903 57003

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026