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 |
|---|---|
| Kuros BioSciences B.V. | INDUSTRY |
Not provided
Not provided
Not provided
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix 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.
Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
In this study, following a screening period of a maximum of 30 days, 100 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Flex Matrix on the assigned side of the spine and Trinity Elite 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. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Week 2, Week 6, Month 3, Month 6 and Month 12. 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 Flex Matrix | Experimental | MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side |
|
| Trinity Elite | Active Comparator | Trinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnetOs Flex Matrix | Device | Procedure: Instrumented Posterolateral Lumbar 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/thoracolumbar fusion assessed by plain radiographs. | Month 6 and Month 12 |
| Radiographic Fusion by CT Scan | The rate of posterolateral lumbar/thoracolumbar 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. | Screening up to 12 Months post-op |
| Safety Endpoint - number of patients with Serious Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesar Silva, MD | Contact | 9702156793 | cesar.silva@kurosbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Parallel Assignment, Intra-patient control. Each patient serves as their own control.
Not provided
Not provided
Not provided
Not provided
| Trinity Elite |
| Device |
Procedure: Instrumented Posterolateral Lumbar Fusion |
|
| Month 6 |
| Functional Outcome by Oswestry Disability Index | Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability. | Screening, Week 2, Week 6, Month 3, Month 6, Month 12 |
| Back and Leg Pain by Visual Analog Pain Scale (VAS) | Change in 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. | Screening, Week 2, Week 6, Month 3, Month 6, and Month 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 lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise. | Screening, Week 2, Week 6, Month 3, Month 6, and Month 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, Month 6, and Month12 |
The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
| Screening up to 12 Months post-op |
| 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 | 12 Months |
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| MedStar Health Research Institute | Recruiting | Columbia | Maryland | 21044 | United States |
|
| Michigan Orthopedic Surgeons | Recruiting | Bloomfield Hills | Michigan | 48033 | United States |
|
| Pinehurst Surgical Clinic | Recruiting | Pinehurst | North Carolina | 28374 | United States |
|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Huntsman Spinal Clinic | Recruiting | Salt Lake City | Utah | 84124 | United States |
|
| Inova Healthcare | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided