Clinical trial NCT05114135: TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
Official title: First-in-man Safety and Performance of OSTEO3 ZP PUTTY in Subjects Undergoing Transforaminal Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Degenerative Spondylolisthesis
Lumbar Spinal Stenosis
Keywords: synthetic bone graft, TLIF, Fusion
Lead sponsor: OssDsign
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 40-65-year-old adults requiring one level instrumented spine fusion
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Safety: Incidence of device-related serious adverse events
timeFrame: 24 months
measure: Percentage of subjects with evidence of interbody fusion being achieved in 12 months post-surgery
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry Disability Index questionnaire to assess Quality of life
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Visual Analog Score to measure pain
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: SF-36 short form to assess change in how the subjects back pain has affected their quality of life.
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Maintenance or Improvement in Neurological function
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Safety: Incidence rate and type of device-related Adverse events
timeFrame: 24 months
measure: Bone Fusion Success
timeFrame: 3, 6 and 24 months
measure: Neurological outcome - Maintenance or improvement of sensory response at dermatomal levels operated in each leg when compared to baseline scores
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Neurological outcome - Maintenance or improvement in patellar and Achilles deep tendon reflexes in each leg when compared to baseline scores
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Neurological outcome - Maintenance or improvement of muscle strength at all muscle sites assessed in each leg when compared to baseline scores
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: 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.
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: 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
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
measure: Absence of Babinski's sign
timeFrame: 3,6,12 and 24 months (unless fused at 12 months)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Buda Health Center, Királyhágó u. 1-3.
Study officials:
affiliation: National Spine Centrer, Buda Health Center, Budapest
name: Peter P Varga, MD
role: PRINCIPAL_INVESTIGATOR
References: