New bone graft material could improve spine surgery outcomes
NCT ID NCT03853356
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study is testing a material called Orthoss®, made from granules, to help bones in the spine fuse together after surgery. The trial includes 65 adults with lower back problems like slipped discs or narrowing of the spine canal. Doctors will check if the bones fuse properly and if patients feel better over 24 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orthoss® granules (bone graft extender)
- What this could lead to
- If successful, Orthoss® could provide a safe and effective option to help spine bones fuse together after surgery, potentially reducing the need for additional bone grafts.
- What could go wrong
- This is a small, early-stage study (65 people) with no control group, so results may not apply broadly. The main risk is that the fusion may not occur as expected, requiring further surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2019
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Orthoss® mixed with local bone and pedicle bone marrow aspirate in lumbar spondylodesis by using transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) techniques in the 1-2 levels.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Klinikum Magdeburg gGmbH
Magdeburg, Germany
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Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
Augsburg, Germany
-
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
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