Evidence For Fusion In Spine With Orthoss® (EFFISO)

February 27, 2023 updated by: Geistlich Pharma AG
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).

Study Overview

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

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Augsburg, Germany
        • Recruiting
        • Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
        • Contact:
        • Principal Investigator:
          • Ehab Shiban, Prof.
      • Düsseldorf, Germany
        • Suspended
        • Universitätsklinikum Düsseldorf
      • Magdeburg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

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.
1-4 weeks; 3, 6, 12 and 24 months
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".
1-4 weeks, 3,6,12 and 24 months
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 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".
1-

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Despoina Natsiou Schmiady, Dr., Geistlich Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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