None listed
Conditions
Brief summary
The overall objective of this study is to evaluate the KDD in maintaining disc height in subjects undergoing single level microdiscectomy as measured by DHI.
Interventions
- The Kunovus™ System is a sterile system of medical instruments for spinal access and delivery of the nucleus implant materials to the annular cavity. The Kunovus™ System is a unique nested set of sterile device delivery instruments that allows for the deployment of the KDD via a single working cannula. This approach is tissue sparing and significantly less invasive than other disc replacement options. The Kunovus™ System is comprised of the following:
1) Disc Accessing Kit (DAK-01);
2) Sizing
- The Kunovus™ System is a sterile system of medical instruments for spinal access and delivery of the nucleus implant materials to the annular cavity. The Kunovus™ System is a unique nested set of sterile device delivery instruments that allows for the deployment of the KDD via a single working cannula. This approach is tissue sparing and significantly less invasive than other disc replacement options. The Kunovus™ System is comprised of the following: 1) Disc Accessing Kit (DAK-01); 2) Sizing Unit Kit (SUK-01); 3) Pressure Generating Apparatus (PGA-01); 4) Delivery Instrumentation System - DIS Assembly (DIS-01); 5) Delivery Instrumentation System - Filler Tube / Static Mixer Assembly (DIS-02); 6) Filler Barrel Assembly (FBA); 7) Kunovus™ System Accessories: Extension Tubing, 3-Way Stopcock, Syringes, Guide Wire. - This study consists of 8 visits over approximately 14-15 months. - In this trial, patients will be randomly assigned to receive either the Kunovus Disc Device (KDD) with microdiscectomy or microdiscectomy alone. There is a 50% chance that they will receive microdiscectomy alone. - The implantation procedure (if receive KDD with microdiscectomy) will be done by a team of expert Neurosurgeons/Orthopaedic spine surgeons. The duration of the procedure will be 3-4 hours. - As with any investigational device, the specific risks are not fully known. However, the following are potential risks related to the KDD. 1) Failure of implant stability within the disc cavity or dislodgement or expulsion of implant 2) Possible allergic reaction to the materials (e.g. silicone) in the KDD; Strategies to mange the potential risks: 1) At each study visit, safety will be assessed by evaluation of Adverse Event (AE)s, Serious Adverse Event (SAE)s, Unanticipated Adverse Device Effect (UADE)s, Treatment Emergent Adverse Event (TEAE)s, the incidence of device expulsion or migration, the incidence of device retrieval or attempted device retrieval and the incidence of repeat procedure(s) to the same herniated space. In the event of device failure, expulsion or migration and removal, the Investigator(s) is required to return the device according to the Sponsor’s written Device Retrieval Procedure for evaluation when possible. The investigator(s) is required to document the failure of the device as directed in the established AE reporting procedure. 2) Depending on a patient's allergies to medications, antibiotics may be used during and after the operation to help prevent infection.
Sponsors
Kunovus Technologies Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must read and sign the Human Research Ethics Committee (HREC) approved Informed Consent Form (ICF) before any participation in the trial. Consent will be obtained before any trial-related procedures; 2. Subject aged between 21 to 80 years (inclusive) at the time of the screening and the baseline visits; 3. Subject must have a broad-based intra-annular contained herniation, sub-ligamentous herniation or frankly sequestrated LDH with associated back and buttock, posterior thigh and/or lower leg pain; 4. Subject must have no more than one level of LDH of an intervertebral disc in the lumbar spine region L3 to S1 as confirmed by Magnetic Resonance Imaging (MRI); 5. The Investigator must confirm subject as a suitable candidate for the treatment of the LDH via a microdiscectomy procedure; 6. The disc that is targeted for treatment must have a height of at least 8 mm in the centre as measured in the mid-sagittal plane; 7. Subject must be willing and able to complete trial required procedures and assessments and complete follow-up visit requirements for one year following the surgery; 8. Subject must be able to read and understand English or a language(s) for which a health-services accredited interpreter can administer the reported questionnaires/assessments and the ICF to the subject.
Exclusion criteria
1. Subject has a known allergy to silicone or barium sulphate; 2. Subject has a history of osteoporosis, defined as a T-score of -2.5 or lower, confirmed by a Dual-Energy X-ray Absorptiometry (DEXA) scan completed within two years before the surgery; 3. Subject has more than one level of lumbar spinal disc herniation; 4. Subject has had prior lumbar surgery at any level; 5. Subject requires a spinal fusion of the herniated disc; 6. Subject has back or leg pain of non-spinal or unknown aetiology; 7. Subject has an implanted spinal cord stimulator; 8. Subject has a spinal deformity or disease of the spine, or any of the following: multiple sclerosis, cerebral palsy, spinal cord injury, tumour in the spine, motor neuron disease, arachnoiditis, or systemic inflammatory arthritis. 9. Subject has a Body Mass Index (BMI) > 40 kg/m2; 10. Subject has spondylolisthesis of the target disc that is more than Grade 1 and a disc height loss of more than 20% compared with the cephalad disc; 11. The subject is pregnant, lactating, or wishes to become pregnant within 12 months post surgery; 12. The subject is currently receiving workers compensation or in any litigation or confliction with third-party payers (including Motor Vehicle Accident insurers or the Centrelink); 13. Subject has an illness that decreases the probability of survival to the one-year trial endpoint; 14. The subject is expected to undergo a major elective spinal procedure during the duration of the trial; 15. The subject is currently participating or has participated in another investigational study within 30 days before signing the Informed Consent, or plans to participate in any other clinical research study while participating in this trial; 16. Subject has the evidence of active infection; 17. Subject has implanted pacemakers; 18. Subject with un-controlled epilepsy; 19. The subject does not meet the surgical eligibility criteria; 20. Subject with a condition or circumstance which, in the opinion of the Investigator, may put the subject at risk if he/she participates in the trial, may confound the trial results or may interfere with the subject’s participation in the trial
Outcome results
None listed