A MultiCenter Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy.
- Conditions
- spinal stenosis or disc herniation1002321310009720
- Registration Number
- NL-OMON32769
- Lead Sponsor
- Fidia Advanced Biopolymers (FAB) S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
• Age 18 * 75 years;
• Scheduled for elective single or two*level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis or disk herniation.
• Subjects who have failed conservative care for at least 6 weeks.
• At least 25% narrowing of the central, lateral or foraminal spinal canal compared to the adjacent levels.
• Radiographic confirmation of any one of the following:
o Evidence of the tecal sac and/or cauda equina compression
o Evidence of nerve root impingement (displacement or compression) by either osseous or non*osseous elements
o Evidence of hypertrophic facets with canal encroachment
• Skeletally mature.
• Able to understand this clinical study and willing and able to participate in the study follow*up according to the protocol.
• Understand and read country national language at elementary level.
• Signed informed consent.
• Women must be one of the following:
o Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status
o Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
o Abstinent (at the discretion of the investigator) or,
o If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double*barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy.
• Women of childbearing potential must have a negative serum β*human chorionic gonadotropin (β*hCG) pregnancy test at screening, or a negative urine pregnancy test at baseline or screening.
• Systemic infection such as AIDS, HIV, and active hepatitis.
• Systemic Lupus erythematosus.
• Contraindication to MRI (e.g. any electrically, magnetically or mechanically activated implants).
• Known allergic reaction to MRI contrast.
• Instrumented fusion (Exception: non*instrumented fusion permissible).
• Postoperative wound treatment planned with suction drainage device (Exception: treatment with gravity drainage device allowed).
• Patient has post traumatic vertebral body compromise or fracture at surgery level.
• Prior lumbar spine surgery at surgery level.
• Undergoing treatment for tumor or bony traumatic injury to the lumbar spine.
• Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
• Significant symptomatic peripheral vascular disease (at the discretion of the investigator).
• Active malignancy defined as history of invasive malignancy, except if the patient has received a treatment and has displayed no clinical signs and symptoms for at least 5 years (excludes basal cell carcinoma).
• Infection in the disc or spine, past or present.
• Evidence of active (systemic or local) infection at time of surgery.
• Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease).
• Paget*s disease, osteomalacia or any other metabolic bone disease.
• Taking immunosuppressants or steroids which have the potential to interfere with bone/soft tissue healing.
• Morbid obesity (BMI >= 40).
• Is a prisoner.
• A recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact study outcome or participation.
• Participation in a clinical trial of another investigational drug or device within
the past 30 days.
• Known allergies to any of the components of the investigational device.
Intraoperative exclusion criteria
• Dural entry during the surgical procedure.
• Newfound intraspinal tumor.
• Involvement of more than two vertebrae levels.
• Epidural fat placement.
• Use of steroid solution.
• Intraoperative decision to use a suction instead of a gravity drainage device.
• Intraoperative decision to leave a hemostatic agent at the surgery site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Frequency and severity of adverse events (AE) (including surgical<br /><br>complications). All AE will be monitored and evaluated continuously.<br /><br>Comparisons of AE between the interventional and control group will be made at<br /><br>6 and 12 month follow-ups. Additional comparisons at any point considered as<br /><br>necessary by the Safety Officer.<br /><br><br /><br>Primary variables<br /><br>Efficacy: Extent of epidural fibrosis and adhesions as measured on MRI after 6<br /><br>and 12 month follow*up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary variables<br /><br>• Patient Reported Outcomes:<br /><br>o Oswestry Disability Index (ODI) v2.1<br /><br>o Pain at back/buttocks (NRS)<br /><br>o Pain at legs (NRS)<br /><br>o SF-36v2.0<br /><br>o EQ-5D<br /><br>o Zurich Claudication Questionnaire (ZCQ)<br /><br>• Neurological status.<br /><br>• Blood loss, surgery time, use of cell savers,<br /><br>• Changes in clinical laboratory hematologic evaluations.<br /><br>• Immunologic response.</p><br>