Clinical trial NCT05037968: MagnetOs Flex Matrix Compared to Trinity Elite Mixed with Local Autograft in Patients Undergoing Up to Four-level Instrumented Posterolateral Fusion
Official title: A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed with Local Autograft Compared to Trinity Elite Mixed with Local Autograft in Patients Undergoing Up to Four-level Instrumented PoSterolatEral Lumbar/thoraco-lumbar Fusion (PLF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Spine Fusion
Leg Pain And/or Back Pain
Keywords: Degenerative Disc Disease
Spine Fusion
Lead sponsor: Kuros Biosurgery AG
Sponsor class: INDUSTRY
Collaborators: name: Kuros BioSciences B.V.
First posted: 2021-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Intra-patient control. Each patient serves as their own control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.
* Had prior PLF fusion or attempted PLF fusion at the involved levels
* Had previous decompression at the involved levels.
* Women who are or intend to become pregnant within the next 12 months
* 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.
* Receiving treatment with medication interfering with calcium metabolism.
* Had leg pain, and/or back pain related to a benign or malignant tumor.
* Had history or presence of active malignancy.
* Has known substance abuse, psychiatric disorder, or condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
* Is involved in active litigation relating to his/her spinal condition.
* Has participated in an investigational study within 30 days prior to surgery for study devices.

Primary outcomes:
measure: Radiographic Fusion by CT Scan
timeFrame: Month 12
Secondary outcomes:
measure: Radiographic Fusion by Plain Radiographs
timeFrame: Month 6 and Month 12
measure: Radiographic Fusion by CT Scan
timeFrame: Month 6
measure: Functional Outcome by Oswestry Disability Index
timeFrame: Screening, Week 2, Week 6, Month 3, Month 6, Month 12
measure: Back and Leg Pain by Visual Analog Pain Scale (VAS)
timeFrame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
measure: Neurologic Status by Physical Exam
timeFrame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
measure: Success Rate
timeFrame: Week 2, Week 6, Month 3, Month 6, and Month12
Other outcomes:
measure: Safety Endpoint - number of patients with Adverse Events
timeFrame: Screening up to 12 Months post-op
measure: Safety Endpoint - number of patients with Serious Adverse Events
timeFrame: Screening up to 12 Months post-op
measure: Safety Endpoint - number of patients with Adverse Device Effects
timeFrame: 12 Months
measure: Safety Endpoint - number of patients with Device Related Complications
timeFrame: 12 Months
measure: Health Economic - Duration of Surgery
timeFrame: 12 Months
measure: Health Economic - Duration of Hospitalization
timeFrame: 12 Months
measure: Health Economic - Return to Work
timeFrame: 12 Months
measure: Health Economic - Quality of Life
timeFrame: 12 Months
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Columbia
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Bloomfield Hills
country: United States
facility: Michigan Orthopedic Surgeons
state: Michigan
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
Study officials:
References: