Lumbar Spondylolisthesis Involving L4-L5EFFISONCT03853356
Evidence For Fusion In Spine With Orthoss®
An observational study of Lumbar Spondylolisthesis Involving L4-L5 and Lumbar Spondylolisthesis Involving L5-S1, run by Geistlich Pharma AG at 3 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis
- What is being tested?
- Orthoss
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 3 sitesGermany
- Study dates
- 18 Jan 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
Augsburg
Universitätsklinikum Düsseldorf
Düsseldorf
Klinikum Magdeburg gGmbH
Magdeburg
About this study
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).
Read the 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.
- Conditions
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
- Being tested
- Orthoss
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthossDevice
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Orthoss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
Successful fusion should be based on the translational motion < 3mm as well as on the angular motion < 5° at 6 months.
Measured: 6 months
Secondary outcomes (3)
Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index
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.
Measured: 1-4 weeks; 3, 6, 12 and 24 months
Clinical Outcome Measure - Leg pain
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".
Measured: 1-4 weeks, 3,6,12 and 24 months
Clinical Outcome Measure - Back pain
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".
Measured: 1-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start18 Jan 2019
- Primary completion17 Jul 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spondylolisthesis Involving L4-L5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabiana Martinelli, Study director, Geistlich Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853356
- Sponsor's protocol ID
- 13570-222
- Acronym
- EFFISO
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence For Fusion In Spine With Orthoss®
- ClinicalTrials.gov ID
- NCT03853356
- Acronym / sponsor ID
- EFFISO / 13570-222
- Conditions
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1) | – | Device: OrthossAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthossOrthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate. | Device | Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1) |
Primary outcome
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.
3 secondary outcomes
Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index
Time frame: 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
Clinical Outcome Measure - Back pain
Time frame: 1-
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiana Martinelli study director
Geistlich Pharma AG
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spondylolisthesis Involving L4-L5 and Lumbar Spondylolisthesis Involving L5-S1, run by Geistlich Pharma AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.