Degenerative Disc DiseaseNCT05114135
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
A study testing Osteo3 ZP Putty in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by OssDsign at 1 site in Hungary.
Trial summary
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
- What is being tested?
- Osteo3 ZP Putty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteHungary
- Study dates
- 7 Sep 2021to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been diagnosed with DDD (as defined below), degenerative spondylolisthesis or lumbar spinal stenosis at one spinal level:
- DDD defined as one or more of the following: instability as defined by greater than or equal to 3 mm translation or greater than or equal to 5 degrees angulation, decreased disc height, on average by greater than or equal to 2 mm, but dependent upon the spinal level, scarring/thickening of ligamentum flavum or annulus fibrosis, herniated nucleus pulposus or vacuum phenomenon.
- The subject has failed at least six months of non-operative treatment prior to clinical study enrolment (e.g. bed rest, physical therapy, bracing, traction, drug therapy, etc) and is a candidate for spinal fusion surgery over one vertebral level between, and including, L2 to S1 (i.e. second lumbar to first sacral).
- The subject is 40-65 years old.
- The subject is, in the Investigator's opinion, psychosocially healthy and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Who cannot join
- Subject has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than one level.
- Subject has had prior surgery at any lumbar level.
- Subject has systemic infection or infection at the surgical site.
- History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign).
- Subject has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.).
- Subject is in poor general health or any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory, pulmonary problems, or cardiac disease).
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- Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow up.
- The subject is known to be pregnant/breastfeeding at the time of enrolment or plans to become pregnant during their participation in the clinical study.
- Subject is participating in, or has completed within the last 30 days, another investigational clinical study, which could confound results.
- Morbid obesity defined as a Body Mass Index (BMI) ≥ 40.
- Has or has had a tumour or fracture at the involved level.
- Subject has a condition or requires post-operative medications that may interfere with bone/soft tissue healing (i.e. NSAIDS, oral or parenteral glucocorticoids, immunosuppressants, methotrexate, etc.), or that effect the rate of bone metabolism unless they have undergone a 14 day wash out period prior to surgery.
- Subject is taking medication for treatment of osteoporosis and/or in the Investigator's opinion, spinal instrumentation would be contraindicated.
- Subject has a T-score of less than -2.5 is therefore diagnostic of osteoporosis.
- Subject is involved in on-going litigation concerning their medical condition.
- Subject has a known allergy to silicon.
- Long-term use (longer than 3 months) of opiates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-man Safety and Performance of OSTEO3 ZP PUTTY in Subjects Undergoing Transforaminal Lumbar Interbody Fusion
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures. This will be an open label, prospective, first in man, single-centre clinical study to evaluate the safety and performance of Osteo3 ZP Putty synthetic bone graft in TLIF procedures with instrumented PLF. Safety and performance data obtained in this clinical study will be used to estimate clinical success rates achieved with the use of Osteo3 ZP Putty synthetic bone graft in TLIF procedures. No comparative control group is intended.
The study is expected to run for approximately three years with each subject being followed up for a two- year post-operative period. The target is to recruit approximately 17 subjects to this clinical study, allowing for some subject attrition to get 15 evaluable.
- Being tested
- Osteo3 ZP Putty
- Keywords
- synthetic bone graft, TLIF, Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteo3 ZP PuttyDevice
Also called OssDsign Catalyst
Transforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach.
| Study group | Role | What they receive |
|---|---|---|
| Subject group | Experimental | undergoing instrumented TLIF with instrumented PLF using investigational product as synthetic bone graft Receives: Device: Osteo3 ZP Putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of device-related serious adverse events
Incidence of device-related serious adverse events. Success measured as no treatment-related events occurring in 24 months post-surgery.
Measured: 24 months
Percentage of subjects with evidence of interbody fusion being achieved in 12 months post-surgery
Percentage of subjects with evidence of interbody fusion being achieved in 12 months post-surgery. Assessed as any evidence of bridging bone observed joining the superior and inferior vertebral bodies. Scored using a simple scoring of yes, no or not known if cannot be seen.
Measured: 12 months
Secondary outcomes (12)
Oswestry Disability Index questionnaire to assess Quality of life
Validated off-the-shelf questionnaire asking patients questions about their ability to perform basic life tasks. It will be used to assess both the subject's back pain and how that pain affects the subject's ability to manage in everyday life. The questionnaire is divided into ten sections designed to assess limitations of various activities of daily living. Each section contains six statements and each statement describes a greater degree of difficulty in that activity than the preceding statement. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all sections are added together, giving a possible score of 50. The total is doubled and expressed as a percentage.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Visual Analog Score to measure pain
Subject will score their pain from 0 to 100 by making a mark on a 10cm line where 0 = no pain and 100 = worst pain imaginable. The change in score from baseline (pre-surgical score) will be assessed at the time points below and reported as a percentage change.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
SF-36 short form to assess change in how the subjects back pain has affected their quality of life.
It will be used to assess both the subject's back pain and how that pain affects the subject's ability to manage in everyday life. The questionnaire is divided into eleven sections designed to assess limitations of various activities of daily living. Subject will score each section and the resulting scores are entered into a validated software evaluation tool which produces a result out of 100, allowing percentage change to be assessed from baseline (pre-surgical) score. Change in score will be assessed at the time points below and reported as a percentage change.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Maintenance or Improvement in Neurological function
The subject will be assessed for neurological function by physical examination. Success = maintenance or improvement in neurological function compared to baseline scores for all Neurological assessments described as separate outcome measures below (Outcome measures 9 - 14 below). Subject will be considered to have clinical success if all neurological outcomes (outcomes 9-14) are maintained or improved from baseline assessments.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Safety: Incidence rate and type of device-related Adverse events
Incidence rate and type of device-related Adverse events (AEs) recorded will be described for the 24 months post surgery period
Measured: 24 months
Bone Fusion Success
Presence of bone fusion assessed by CT scans at 3, 6 months and 24 months. Scored as yes or no for presence of a bridge of bone between the superior and inferior vertebral bodies. The results will be reported as percentage of subjects fused at the various timepoints below.
Measured: 3, 6 and 24 months
Neurological outcome - Maintenance or improvement of sensory response at dermatomal levels operated in each leg when compared to baseline scores
Sensory - Decreased sensation will be assessed by evaluating sensation response (e.g., to pin prick, light touch or vibration) for the involved dermatomal levels. The examination method chosen to make these assessments will be left to the discretion of the Investigator. Sensory function will be scored as 0 = Absent, 1 = Impaired, 2 = Normal
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance or improvement in patellar and Achilles deep tendon reflexes in each leg when compared to baseline scores
Reflex - Reflexes of both legs will be evaluated by assessing patellar (knee jerk) and Achilles (ankle jerk) deep tendon reflexes. The Investigator will be asked to indicate whether the knee and ankle reflex response for each leg is normal, decreased, absent or increased.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance or improvement of muscle strength at all muscle sites assessed in each leg when compared to baseline scores
Muscle Strength - Muscle strength of both legs will be assessed bilaterally at the following muscle sites: hip flexors (iliopsoas musculature); knee extensors (quadriceps); ankle dorsiflexors (tibialis transforaminal); ankle plantar flexors (gastrocnemius); and long toe extensors (extensor halluces longus) using the following clinical scale. The worst assessment (no evidence of contractility) will be assigned the lowest clinical score 0 out of 5 while full range of motion against gravity, full resistance will be assigned the highest clinical score 5 out of 5. The following scale will be used to assess muscle strength:
No evidence of contractility 0 Slight contractility, no movement 1 Full range of motion, gravity eliminated (passive movement) 2 Full range of motion with gravity 3 Full range of motion against gravity, some resistance 4 Full range of motion against gravity, full resistance 5
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance of a negative straight leg raising response or improvement of a positive straight leg raising response to negative in each leg when compared to the baseline result.
Straight Leg Raising - The ability of the subject to undergo passive straight leg raising manoeuvres while in the supine position will be assessed for both legs. The results will be recorded as a positive or negative straight leg raise (SLR) for each leg.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance of a negative femoral stretch response or improvement of a positive femoral stretch response to negative in each leg when compared to the baseline result
Femoral Stretch - The ability of the subject to undergo passive femoral stretch manoeuvres while lying on one side will be assessed for both legs. The results will be recorded as a positive or negative femoral stretch for each leg.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Absence of Babinski's sign
Presence or absence of Babinski's sign will be recorded. Absence of Babsinki's sign is considered normal and a success.
Measured: 3,6,12 and 24 months (unless fused at 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start7 Sep 2021
- Primary completion20 Apr 2023
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 40-65-year-old adults requiring one level instrumented spine fusion
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OssDsign
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter P Varga, MD, Principal investigator, National Spine Centrer, Buda Health Center, Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114135
- Sponsor's protocol ID
- SIR202001
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2021
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Safety and Performance of OSTEO3 ZP PUTTY in Subjects Undergoing Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT05114135
- Acronym / sponsor ID
- SIR202001
- Keywords
- synthetic bone graft, TLIF, Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OssDsignIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 9 Nov 2021 (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.
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures. This will be an open label, prospective, first in man, single-centre clinical study to evaluate the safety and performance of Osteo3 ZP Putty synthetic bone graft in TLIF procedures with instrumented PLF. Safety and performance data obtained in this clinical study will be used to estimate clinical success rates achieved with the use of Osteo3 ZP Putty synthetic bone graft in TLIF procedures. No comparative control group is intended.
The study is expected to run for approximately three years with each subject being followed up for a two- year post-operative period. The target is to recruit approximately 17 subjects to this clinical study, allowing for some subject attrition to get 15 evaluable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 40-65-year-old adults requiring one level instrumented spine fusion
| Arm | Type | Receives |
|---|---|---|
| Subject group | Experimental | Device: Osteo3 ZP Puttyundergoing instrumented TLIF with instrumented PLF using investigational product as synthetic bone graft |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has been diagnosed with DDD (as defined below), degenerative spondylolisthesis or lumbar spinal stenosis at one spinal level:
- DDD defined as one or more of the following: instability as defined by greater than or equal to 3 mm translation or greater than or equal to 5 degrees angulation, decreased disc height, on average by greater than or equal to 2 mm, but dependent upon the spinal level, scarring/thickening of ligamentum flavum or annulus fibrosis, herniated nucleus pulposus or vacuum phenomenon.
- The subject has failed at least six months of non-operative treatment prior to clinical study enrolment (e.g. bed rest, physical therapy, bracing, traction, drug therapy, etc) and is a candidate for spinal fusion surgery over one vertebral level between, and including, L2 to S1 (i.e. second lumbar to first sacral).
- The subject is 40-65 years old.
- The subject is, in the Investigator's opinion, psychosocially healthy and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Key exclusion criteria (17 listed)
- Subject has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than one level.
- Subject has had prior surgery at any lumbar level.
- Subject has systemic infection or infection at the surgical site.
- History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign).
- Subject has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.).
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 |
|---|---|---|
| Osteo3 ZP PuttyAlso: OssDsign CatalystTransforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach. | Device | Subject group |
Primary outcome
Safety: Incidence of device-related serious adverse events
Time frame: 24 months
Incidence of device-related serious adverse events. Success measured as no treatment-related events occurring in 24 months post-surgery.
Percentage of subjects with evidence of interbody fusion being achieved in 12 months post-surgery
Time frame: 12 months
Percentage of subjects with evidence of interbody fusion being achieved in 12 months post-surgery. Assessed as any evidence of bridging bone observed joining the superior and inferior vertebral bodies. Scored using a simple scoring of yes, no or not known if cannot be seen.
12 secondary outcomes
Oswestry Disability Index questionnaire to assess Quality of life
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Visual Analog Score to measure pain
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
SF-36 short form to assess change in how the subjects back pain has affected their quality of life.
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Maintenance or Improvement in Neurological function
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Safety: Incidence rate and type of device-related Adverse events
Time frame: 24 months
Bone Fusion Success
Time frame: 3, 6 and 24 months
Neurological outcome - Maintenance or improvement of sensory response at dermatomal levels operated in each leg when compared to baseline scores
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance or improvement in patellar and Achilles deep tendon reflexes in each leg when compared to baseline scores
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance or improvement of muscle strength at all muscle sites assessed in each leg when compared to baseline scores
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance of a negative straight leg raising response or improvement of a positive straight leg raising response to negative in each leg when compared to the baseline result.
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Neurological outcome - Maintenance of a negative femoral stretch response or improvement of a positive femoral stretch response to negative in each leg when compared to the baseline result
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Absence of Babinski's sign
Time frame: 3,6,12 and 24 months (unless fused at 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Peter P Varga, MD principal investigator
National Spine Centrer, Buda Health Center, Budapest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteo3 ZP Putty in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by OssDsign at 1 site in Hungary.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Incidence of device-related serious adverse events (time frame: 24 months). The study lists 2 primary outcomes in all. 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 10 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.