Non-interventional PMCF-study: an application observation of LEANDER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027500

Enrollment

Registered

2021-12-29

Start date

2022-01-24

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Tumorous, inflammatory and traumatic diseases and injuries of the cervical spine (C3 to C7) S12.2 S12.9 M53.22 M53.82 M53.92 D16.6 C41.2 M46.52 M46.82 M46.92

Interventions

Group 1: Data from patients who receive a cervical vertebral body replacement with the LEANDER are collected before, during and after (postoperatively before discharge, 3 months postoperatively, 12 mo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients treated with the LEANDER vertebral body replacement - Patients who are skeletally matured at the time of surgery - Patients who are willing and able to provide an informed consent

Exclusion criteria

Exclusion criteria: - Pregnant women or women who plan to become pregnant during the study period. - Patients who are already participating in another study - Patients with any condition that would interfere with the patients abilty to comply with study instructions or might confound the study interpretation - Patients with any absolute contraindications listed in the instructions for use of the LEANDER.

Design outcomes

Primary

Measure	Time frame
Improvement in patient-reported neck-specific disability measured by Neck Disability Index (NDI) score from baseline to 3 months postoperatively.	—

Secondary

Measure	Time frame
- Positional stability of the implant at all postoperative time points - Non-union signs at all postoperative time points - Change in height of the operated segment and change in lordosis profile of the cervical spine between baseline (preoperative) and all postoperative time points - Surgeon satisfaction regarding instrument handling (intraoperative) - Change in patient-reported pain and neck-specific disability (VAS arms and neck, NDI) between baseline (preoperative) and 3 and 12 months postoperatively - Safety of the implant at all time points	—

Measure

Time frame

- Positional stability of the implant at all postoperative time points - Non-union signs at all postoperative time points - Change in height of the operated segment and change in lordosis profile of the cervical spine between baseline (preoperative) and all postoperative time points - Surgeon satisfaction regarding instrument handling (intraoperative) - Change in patient-reported pain and neck-specific disability (VAS arms and neck, NDI) between baseline (preoperative) and 3 and 12 months postoperatively - Safety of the implant at all time points

—

Countries

Germany

Contacts

Public ContactRoland Rißel

Kliniken Ostalb - Stauferklinikum Schwäbsich Gmünd

jutta.schoell@kliniken-ostalb.de071717011443

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026