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Status:

ACTIVE_NOT_RECRUITING

Evidence For Fusion In Spine With Orthoss®

Lead Sponsor:

Geistlich Pharma AG

Conditions:

Lumbar Spondylolisthesis Involving L4-L5

Lumbar Spondylolisthesis Involving L5-S1

Eligibility:

All Genders

18+ years

Brief Summary

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

Detailed Description

This clinical investigation is a prospective, non-interventional, uncontrolled clinical trial, organized to generate clinical data on performance and safety of Orthoss® as a bone graft extender mixed ...

Eligibility Criteria

Inclusion

  • The patient (male or female) must be 18 years or older
  • The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis
  • If the patient is of child-bearing potential, the patient confirms not to be pregnant
  • The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication
  • The patient will not participate in another clinical investigation during this clinical investigation

Exclusion

  • General contraindications for surgical treatment are present
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
  • The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon
  • The patient is pregnant or nursing
  • Women of childbearing age who are not using a highly effective method of birth control
  • The patient has acute or chronic infection at the surgical site
  • The patient has a known allergy to bovine bone material
  • The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination
  • Vulnerable population
  • Patient is currently participating, or has participated in another clinical investigation within 6 months

Key Trial Info

Start Date :

January 18 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT03853356

Start Date

January 18 2019

End Date

January 1 2027

Last Update

September 10 2025

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik

Augsburg, Germany

2

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

3

Klinikum Magdeburg gGmbH

Magdeburg, Germany