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Compares treatment options for Degenerative Disc Disease
Official title MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
ClinicalTrials.gov ID: NCT05037968
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved...
- 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...
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
- Chicago, Illinois, United States
- Columbia, Maryland, United States
- Bloomfield Hills, Michigan, United States
- Pinehurst, North Carolina, United States
- Columbus, Ohio, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States; Chicago, Illinois, United States; Columbia, Maryland, United States; Bloomfield Hills, Michigan, United States; Pinehurst, North Carolina, United States; Columbus, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.