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Evidence For Fusion In Spine With Orthoss® | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Evidence For Fusion In Spine With Orthoss®

NCT03853356•Geistlich Pharma AG

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 with local bone at ratio of 1:1 and pedicle bone marrow aspirate in lumbar spondylodesis involving 1-2 levels. (Orthoss® is CE marked for this indication). If you as a patient have a wear and tear disease of the spine, an operation serves to restore the stability of the spinal column. In order to promote a bony build-up of the lumbar spine segment (fusion), bone replacement material is used in your case as standard. The aim of this observational study is to determine fusion in order to address clinical performance of that bone replacement material.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•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

Locations (3)

Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik

Augsburg, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Klinikum Magdeburg gGmbH

Magdeburg, Germany

Key Dates

Start Date

January 18, 2019

Primary Completion Date

July 17, 2025

Completion Date

January 1, 2027

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Lumbar Spondylolisthesis Involving L4-L5Lumbar Spondylolisthesis Involving L5-S1Lumbar Spinal StenosisLumbar Disc Degeneration

Interventions

Orthoss

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evidence For Fusion In Spine With Orthoss®

Inclusion Criteria

Exclusion Criteria

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