Evaluating Orthoss® for spinal fusion in lumbar surgeries
Evidence For Fusion In Spine With Orthoss®
This study is testing how well Orthoss®, a bone graft extender, works for people having surgery on their lower back to see if it helps them heal better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geistlich Pharma AG Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Augsburg and 2 other locations) |
| Trial ID | NCT03853356 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and safety of Orthoss®, a bone graft extender, in patients undergoing lumbar spondylodesis involving one or two levels (L4-L5 and/or L5-S1). The trial is non-interventional and will collect clinical data on the effectiveness of Orthoss® when mixed with local bone and pedicle bone marrow aspirate. Participants will be monitored for fusion outcomes to evaluate the clinical performance of this bone replacement material.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with degenerative disc disease, dysplastic spondylolisthesis, or lumbar stenosis.
Not a fit: Patients with general contraindications for surgical treatment or a recent history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients with lumbar spine conditions.
How similar studies have performed: Other studies have shown promising results with similar bone graft extenders, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augsburg and 2 other locations
- Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik — Augsburg, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Suspended)
- Klinikum Magdeburg gGmbH — Magdeburg, Germany (Recruiting)
Study contacts
- Study coordinator: Nina Schnüriger
- Email: nina.schnueriger@geistlich.com
- Phone: +41 41 492 68 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.