Degenerative Disc Disease Clinical Trial
— PRECISEOfficial title:
A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOsTM Flex Matrix Compared to Cell Based Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
NCT number | NCT05037968 |
Other study ID # | CT-003 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | July 2025 |
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. A cellular based allograft will also be used according to its latest IFU approved in the US. Specifically, the cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent. - Male or female patient = 18 years old. - Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) - Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment. Exclusion Criteria: - Requires > four-level fusion or expected to need secondary intervention within one year following surgery. - To treat conditions in which general bone grafting is not advisable. - In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible). - In case of significant vascular impairment proximal to the graft site. - In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing. - In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). - When intraoperative soft tissue coverage is not planned or possible. - Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space. - Receiving treatment with medication interfering with calcium metabolism. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kuros Biosurgery AG | Simplified Clinical Data Systems, LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Safety Endpoint - number of patients with Serious Adverse Events | The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery | 12 Months | |
Other | 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 | |
Other | 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 | |
Other | Health Economic - Duration of Surgery | Duration of surgery in minutes. | 12 Months | |
Other | Health Economic - Duration of Hospitalization | Duration of hospital stay in days. | 12 Months | |
Other | Health Economic - Return to Work | Time to return to work in days. | 12 Months | |
Other | Health Economic - Quality of Life | Change in Quality of Life measurement using EuroQol-5D/5L scoring | 12 Months | |
Primary | 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 | |
Secondary | Radiographic Fusion by Plain Radiographs | The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs. | Week 2, Week 6, Month 3 | |
Secondary | 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. | Month 6 | |
Secondary | 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. | Week 2, Week 6, Month 3, Month 6, Month 12 | |
Secondary | 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. | Week 2, Week 6, Month 3, Month 6, and Month 12 | |
Secondary | 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. | Week 2, Week 6, Month 3, Month 6, and Month 12 | |
Secondary | 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 |
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