Actively Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Led by Kuros Biosurgery AG · Updated on 2026-02-25
100
Participants Needed
7
Research Sites
129 weeks
Total Duration
On this page
Sponsors
K
Kuros Biosurgery AG
Lead Sponsor
K
Kuros BioSciences B.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is able to understand and provide written informed consent
- Male or female patient 18 years old or older
- 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 at least 3 months prior to enrollment
You will not qualify if you...
- Requires more than four-level fusion or expected to need secondary intervention within one year after surgery
- Had prior posterolateral fusion or attempted fusion at the involved spinal levels
- Had previous decompression surgery at the involved levels
- Women who are or intend to become pregnant within the next 12 months
- Conditions where bone grafting is not advisable
- Surgical site may be exposed to excessive impact or stresses beyond fixation hardware strength
- Significant vascular impairment near the graft site
- Severe metabolic or systemic bone disorders affecting bone or wound healing
- Acute or chronic infections in the operated area
- Intraoperative soft tissue coverage not planned or possible
- Receiving medications interfering with calcium metabolism
- Leg or back pain related to benign or malignant tumor
- History or presence of active malignancy
- Known substance abuse, psychiatric disorder, or condition affecting healing or protocol compliance
- Involved in active litigation related to spinal condition
- Participated in investigational study within 30 days prior to surgery
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hartford Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
2
MedStar Health Research Institute
Columbia, Maryland, United States, 21044
Actively Recruiting
3
Michigan Orthopedic Surgeons
Bloomfield Hills, Michigan, United States, 48033
Actively Recruiting
4
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Huntsman Spinal Clinic
Salt Lake City, Utah, United States, 84124
Actively Recruiting
7
Inova Healthcare
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Cesar Silva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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