Actively Recruiting
A Prospective, Randomized Multi-center Study to Assess MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Lumbar/Thoraco-lumbar Fusion
Led by Kuros Biosurgery AG · Updated on 2026-02-25
100
Participants Needed
7
Research Sites
N/A
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 research aims to evaluate the performance of MagnetOs Flex Matrix compared to Trinity Elite when mixed with local autograft in patients undergoing up to four-level instrumented posterolateral lumbar or thoraco-lumbar fusion surgery. It focuses on patients with degenerative disc disease experiencing leg and/or back pain who have not responded to conservative treatments. This is a phase IV post-marketing study conducted by Kuros Biosurgery AG to assess these bone graft extender products in a surgical setting. Patients will be randomly assigned to receive MagnetOs Flex Matrix on one side of the spine and Trinity Elite on the other side during their fusion surgery. MagnetOs Flex Matrix will be mixed with local autograft bone in equal volumes (1:1) and applied per spine level, while Trinity Elite, a cellular-based allograft containing cancellous and demineralized cortical bone, will be used similarly on the opposite side. The surgical procedure and fusion levels (up to four) are determined by the surgeon's judgment. Participants will be followed from screening through surgery and for 12 months afterward, with evaluations at discharge, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. Assessments include radiographs at all visits and CT scans at 6 and 12 months to measure spinal fusion. Additional measures include back and leg pain scales, functional disability indexes, neurologic exams, and fusion success rates. The primary outcome is fusion assessed by CT scan at 12 months after surgery.
CONDITIONS
Brief 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...
- Able to read, understand, and provide written informed consent
- Male or female 18 years or older
- Have leg 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 surgery within one year
- Prior posterolateral fusion or attempted fusion at the involved spine levels
- Previous decompression surgery at the involved spine levels
- Women who are or plan to become pregnant within 12 months
- Conditions where bone grafting is not advisable
- Surgical sites subject to excessive impact or stress beyond fixation hardware load strength
- Significant vascular impairment near the graft site
- Severe metabolic or systemic bone disorders affecting healing
- Acute or chronic infections in the operated area
- Intraoperative soft tissue coverage not planned or possible
- Treatment with medications interfering with calcium metabolism
- Leg/back pain related to tumors
- History or presence of active cancer
- Known substance abuse, psychiatric disorder, or conditions affecting healing or compliance
- Active litigation related to spinal condition
- Participation in an investigational study within 30 days before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants will undergo up to four-level instrumented posterolateral fusion surgery where they will receive MagnetOs Flex Matrix on one side of the spine and Trinity Elite on the other side at the diseased levels.
1 surgical visit (in-person)
Duration - 12 months
Participants will be followed up after surgery to monitor healing and recovery, including radiographs and clinical assessments.
Visits at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12 (in-person)
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
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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