Spinal Stenosis Clinical Trial
— ENHANCEOfficial title:
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery
Verified date | March 2024 |
Source | Asahi Kasei Pharma Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | January 30, 2024 |
Est. primary completion date | November 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Hôpital Sacré-Coeur de Montréal | Montreal | Quebec |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Centre Hospitalier Universitaire de Québec Laval | Québec | Quebec |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Asahi Kasei Pharma Corporation | Emergent Clinical Consulting, LLC |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events | 24 months | ||
Primary | Summary of Neurological Status | 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. | 24 months | |
Secondary | Successful Fusion | 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. | 24 months | |
Secondary | Oswestry Low Back Pain Disability Questionnaire (ODI) | 24 months | ||
Secondary | 36-Item Short Form Survey (SF-36v2®) | 24 months | ||
Secondary | 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 |
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