Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orthopaedic Institute of Western Kentucky | UNKNOWN |
| Simplified Clinical Data Systems, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery.
In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Day 0, Week 6, Month 3. CT scans will only be obtained at Month 6 and Month 12.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagnetOs Putty | Experimental | MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side. |
|
| Local autograft | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnetOs Putty | Device | Procedure: Instrumented posterolateral spine fusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion by CT Scan | The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion by Plain Radiographs | The rate of posterolateral lumbar fusion assessed by plain radiographs | Week 2, Week 6, Month 3 |
| Posterolateral lumbar fusion assessed by CT-scan | The rate of posterolateral lumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint - number of patients with Adverse Events | The number of patients with Adverse Events from Screening up to Month 12 after surgery | 12 Months |
| Safety Endpoint - number of patients with Serious Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pascal Longlade, MD | Kuros BioSciences B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Parallel Assignment Intra-patient control. Each patient serves as their own control.
Not provided
Not provided
Not provided
Not provided
| Month 6 |
| Interbody lumbar fusion assessed by plain radiographs | The rate of interbody lumbar fusion assessed by plain radiographs at Week 2, Week 6, Month 3, Month 6, and Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior vertebral bodies | Week 2, Week 6, Month 3, Month 6, Month 12 |
| Functional Outcome by Oswestry Disability Index | Change in functional score using Oswestry Disability Index questionnaire. Patient-completed survey provides subjective percentage score for level of function (disability) in activities of daily living. Score rage 0-100 percent. The lower the percentages indicate higher functionality; 0-20% minimal disability, 80-100% significant disability. | Week 2, Week 6, Month 3, 6, and 12 |
| General, back and Leg Pain by Visual Analog Pain Scale | Change in general, back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity. | Week 2, Week 6, Month 3, 6, and 12 |
| Neurologic Status by Physical Exam | Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for the lower extremities, specifically in reflexes, muscle strength, sensory, and straight leg raise. | Week 2, Week 6, Month 3, 6, and 12 |
| Success Rate | Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery | Week 2, Week 6, Month 3, 6, and 12 |
The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
| 12 Months |
| Safety Endpoint - number of patients with Adverse Device Effects | The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery | 12 Months |
| Safety Endpoint - number of patients with Device Related Complications | The number of patients with any complications considered to device related with 12 months after surgery | 12 Months |
| Health Economic - Duration of Surgery | Duration of surgery in minutes | 12 Months |
| Health Economic - Duration of Hospitalization | Duration of hospital stay in days | 12 Months |
| Health Economic - Return to Work | Time to return to work in days | 12 Months |
| Health Economic - Quality of Life | Change in Quality of Life measurement using EuroQol 5D/5L scoring | Week 6, Month 3, 6, and 12 |