TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)

NCT ID: NCT05114135

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2024-03-14

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Lumbar Spinal Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subject group

undergoing instrumented TLIF with instrumented PLF using investigational product as synthetic bone graft

Group Type: EXPERIMENTAL

Osteo3 ZP Putty

Intervention Type: DEVICE

Transforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach.

Interventions

Osteo3 ZP Putty

Transforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach.

Intervention Type: DEVICE

Other Intervention Names

OssDsign Catalyst

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OssDsign

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter P Varga, MD

Role: PRINCIPAL_INVESTIGATOR

National Spine Centrer, Buda Health Center, Budapest

Locations

Buda Health Center, Királyhágó u. 1-3.

Budapest, , Hungary

Countries

Hungary

Other Identifiers

SIR202001

Identifier Type: -

Identifier Source: org_study_id