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Evidence For Fusion In Spine With Orthoss® (EFFISO)

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ClinicalTrials.gov Identifier: NCT03853356
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Geistlich Pharma AG

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).

Condition or disease Intervention/treatment
Lumbar Spondylolisthesis Involving L4-L5 Lumbar Spondylolisthesis Involving L5-S1 Lumbar Spinal Stenosis Lumbar Disc Degeneration Device: Orthoss

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evidence For Fusion In Spine With Orthoss®
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1) Device: Orthoss
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.




Primary Outcome Measures :
  1. Fusion rate [ Time Frame: 6 months ]
    Successful fusion should be based on the translational motion < 3mm as well as on the angular motion < 5° at 6 months.


Secondary Outcome Measures :
  1. 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.

  2. 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 intesity 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".

  3. Clinical Outcome Measure - Back pain [ Time Frame: 1- ]
    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 intesity 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
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
  • Previous low back surgery failure: foraminectomies and laminectomies
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853356


Locations
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Germany
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Markus Konieczny, MD    211 - 81 18314 ext +49    Markus.Konieczny@med.uni-duesseldorf.de   
Principal Investigator: Markus Konieczny, MD         
Klinikum Magdeburg gGmbH Recruiting
Magdeburg, Germany
Contact: Jörg Franke, MD    0391 791-5201 ext +49    Joerg.Franke@Klinikum-Magdeburg.de   
Principal Investigator: Jörg Franke, MD         
Klinikum rechts der Isar Technische Universität München Recruiting
Munich, Germany
Contact: Ehab Shiban, MD    089 / 4140 9715 ext +49    ehab.shiban@tum.de   
Principal Investigator: Ehab Shiban, MD         
Sponsors and Collaborators
Geistlich Pharma AG

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Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT03853356     History of Changes
Other Study ID Numbers: 13570-222
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis