- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853356
Evidence For Fusion In Spine With Orthoss® (EFFISO)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Despoina Natsiou Schmiady, Dr.
- Phone Number: +41 41 492 68 11
- Email: despoina.natsiou@geistlich.com
Study Contact Backup
- Name: Nina Schnüriger
- Phone Number: +41 41 492 68 37
- Email: Nina.Schnueriger@geistlich.com
Study Locations
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-
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Augsburg, Germany
- Recruiting
- Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
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Contact:
- Ehab Shiban, Prof.
- Phone Number: +49 089 / 4140 9715
- Email: ehab.shiban@uk-augsburg.de
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Principal Investigator:
- Ehab Shiban, Prof.
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Düsseldorf, Germany
- Suspended
- Universitätsklinikum Düsseldorf
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Magdeburg, Germany
- Recruiting
- Klinikum Magdeburg gGmbH
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Contact:
- Jörg Franke, Prof.
- Phone Number: +49 0391 791-5201
- Email: Joerg.Franke@Klinikum-Magdeburg.de
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Contact:
- Anne Wustmann
- Email: anne.wustmann@klinikum-magdeburg.de
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Principal Investigator:
- Jörg Franke, Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)
All surgical procedures to be performed during this clinical trial are part of the routine procedures for lumbar spondylodesis by using transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) techniques in the 1-2 levels (L4-L5 and/or L5-S1).
Patients will receive surgery according to standard procedures.
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Orthoss® granules.
Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fusion rate
Time Frame: 6 months
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Successful fusion should be based on the translational motion < 3mm as well as on the angular motion < 5° at 6 months.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index
Time Frame: 1-4 weeks; 3, 6, 12 and 24 months
|
Improvement in Oswestry Low Back Disability Index (ODI) of 15 or more at 24 months from the pre-operative value.Zero is equated with no disability and 100 is the maximum disability possible.
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1-4 weeks; 3, 6, 12 and 24 months
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Clinical Outcome Measure - Leg pain
Time Frame: 1-4 weeks, 3,6,12 and 24 months
|
Decrease in Visual Analog Scale for Pain (VAS) for leg by 3/10 or more at 24 months from the pre-operative value.
Patients rated their leg pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
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1-4 weeks, 3,6,12 and 24 months
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Clinical Outcome Measure - Back pain
Time Frame: 1-
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Decrease in Visual Analog Scale for Pain (VAS) for back by 3/10 or more at 24 months from the pre-operative value.
Patients rated their back pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
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1-
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Despoina Natsiou Schmiady, Dr., Geistlich Pharma AG
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13570-222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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