Primary objectives of the study are (i) to evaluate short*term safety of HYALOSPINE and (ii) to evaluate efficacy of HYALOSPINE in prevention of adhesions and fibrosis following single* or two*level lumbar laminectomy or laminotomy in patients with…
ID
Source
Brief title
Condition
- Joint disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Frequency and severity of adverse events (AE) (including surgical
complications). All AE will be monitored and evaluated continuously.
Comparisons of AE between the interventional and control group will be made at
6 and 12 month follow-ups. Additional comparisons at any point considered as
necessary by the Safety Officer.
Primary variables
Efficacy: Extent of epidural fibrosis and adhesions as measured on MRI after 6
and 12 month follow*up.
Secondary outcome
Secondary variables
• Patient Reported Outcomes:
o Oswestry Disability Index (ODI) v2.1
o Pain at back/buttocks (NRS)
o Pain at legs (NRS)
o SF-36v2.0
o EQ-5D
o Zurich Claudication Questionnaire (ZCQ)
• Neurological status.
• Blood loss, surgery time, use of cell savers,
• Changes in clinical laboratory hematologic evaluations.
• Immunologic response.
Background summary
Extensive epidural scar adhesions, referred as laminectomy membrane, often
occur in the laminectomy defect after spine surgery and can have a role in
unfavourable patient outcome. Formation of dense and thick scar tissue which
adheres to the surgically exposed dura mater and adjacent nerve roots can
result in extradural compression or dura tethering, causing recurrent radicular
pain and physical impairment. Patients who presented with extensive epidural
scarring at the MRI evaluation were more likely to suffer from recurrent pain
compared to patients without signs of extensive scars.
Hyalospine is an implantable device, in form of aqueos gel, to be used as a
mechanical barrier to prevent or decrease post*surgical adhesions.
Study objective
Primary objectives of the study are (i) to evaluate short*term safety of
HYALOSPINE and (ii) to evaluate efficacy of HYALOSPINE in prevention of
adhesions and fibrosis following single* or two*level lumbar laminectomy or
laminotomy in patients with lumbar stenosis or disk herniation.
Secondary objectives are to evaluate differences in pain, neurological status,
function, quality of life outcomes, clinical hematologic laboratory changes,
and immunologic response between the investigational and control groups.
Study design
This study is a prospective randomized double (patient and evaluator) blinded
controlled trial. Patients will be randomized to one of the treatment arms in a
ratio of 1:1. Outcomes will be evaluated at 3 weeks ± 1 weeks, 6 weeks ± 2
weeks, 6 months ± 1 month, 12 months ± 2 months, and at all unplanned visits.
The randomization will occur at the time when the main surgery has been
completed and after the intraoperative exclusion critera have been verified.
Patients who do not meet the intraoperative criteria are not randomised and
excluded from the study. Such patients will not count towards the study sample
size.
Intervention
Hyalospine is a medical device in form of a gel with a final concentration of
30 mg/ml constituted by 18 mg of gellan and 11 mg of HA-S, in 0.9% saline
solution. Hyalospine is an implantable device, in form of aqueos gel, to be
used as a mechanical barrier to prevent or decrease post-surgical adhesions.
The product is presented in glass 2.5 ml syringes and the packaging includes a
suitable canula to help in spinal canal administration.
Study burden and risks
The patient will visit the hospital 6 times during the study. During each visit
questionnaires will be administered and a blood sample will be drawn. At 6 and
12 months an MRI with contrast fluid will be taken. Risks are asociated with
MRI with contrast (headache, allergy), medical device and the general risks
associated with spinal surgery. Benefit of te device is anticipated as less
adhesions and fibrosis at the operative site.
Via Ponte Della Fabbrica
35031 Abano Therme
IT
Via Ponte Della Fabbrica
35031 Abano Therme
IT
Listed location countries
Age
Inclusion criteria
• 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.
Exclusion criteria
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00939406 |
| CCMO | NL29487.072.09 |