Degenerative Spondylolisthesis, Spinal Stenosis
Conditions
Keywords
degenerative spondylolisthesis, spinal stenosis, posterolateral lumber fusion surgery, autograft
Brief summary
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.
Detailed description
This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups. Cohort 1 and Cohort 2 (AK1320 MS group (n=3-7); Control group (n=0-3)) and Cohort 3 and Cohort 4 (AK1320 MS group (n=6-7); Control group (n=0-3)).
Interventions
DRUGAK1320 MS
AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
OTHERControl
Local Autologous Bone + Posterior Fixation
Sponsors
Emergent Clinical Consulting, LLC
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Involved level L1 to S1 2. Use of local autologous bone only. 3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2. 4. Moderate or higher disability as assessed by Oswestry Disability Index. 5. Neurogenic claudication and/or radiculopathy with or without back pain. 6. Male or female over 22 years of age and less than 81 years of age.
Exclusion criteria
1. Prior lumbar decompression or spine fusion attempt (any level). 2. Undergoing concurrent interbody fusion. 3. Requires spinal fusion at more than one lumbar level. 4. Degenerative scoliosis. 5. BMI \> 40. 6. Radiographically confirmed significant spinal instability. 7. Active or recent (within the past two (2) years) worker's compensation litigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events | 24 months | — |
| Summary of Neurological Status | 24 months | Neurological status will be determined preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements: lower extremity motor, dermatomal sensation, reflexes and straight leg raise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Fusion | 24 months | Fusion will be evaluated through CT scans. Successful fusion will be defined as complete bridging bone between the index level transverse processes with a lack of lucency or lucent lines through the fusion mass. |
| Oswestry Low Back Pain Disability Questionnaire (ODI) | 24 months | — |
| 36-Item Short Form Survey (SF-36v2®) | 24 months | — |
| AK1320 plasma concentrations | Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks | — |
Countries
Canada
Outcome results
None listed