Comparing MagnetOs Easypack Putty to Other Bone Grafts in Spine Surgery

A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)

This study is testing if a new bone putty can help people with degenerative disc disease heal better after spine surgery compared to a traditional bone graft mix.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kuros Biosurgery AG (Industry-sponsored)
• Locations: 6 sites (Irvine, California and 5 other locations)
• Trial ID: NCT04679844 on ClinicalTrials.gov

What this trial studies

This post-marketing study evaluates the effectiveness of MagnetOs Easypack Putty as a standalone treatment in patients undergoing posterolateral lumbar fusion for degenerative disc disease. A total of 60 patients will be randomized to receive either MagnetOs Easypack Putty or a combination of Demineralized Bone Matrix and local autograft bone during their surgery. Patients will be monitored through various follow-up visits at discharge, and at 2 weeks, 3 months, 6 months, and 12 months post-surgery to assess the outcomes. The primary endpoint will be analyzed at the 12-month mark, with interim analysis conducted after 30 patients complete their 6-month visit.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with segmental mechanical spinal instability requiring up to two-level instrumented posterolateral lumbar fusion.

Not a fit: Patients who do not have mechanical instability or those who have not failed conservative treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and reliable option for spinal fusion surgery, potentially improving recovery and outcomes for patients with degenerative disc disease.

How similar studies have performed: Other studies have shown promising results with similar synthetic bone graft extenders, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
* Male or female patient ≥ 18 years old.
* Patients with segmental mechanical spinal instability requiring arthrodesis surgery.

Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:

1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
2. decreased disc height by \> 2 mm, but dependent upon the spinal level
3. Grade II or more listhesis
4. TLICS equal or greater than 5
5. Unstable burst fracture

   * 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 (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.

Exclusion Criteria:

* Requires \> two-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, history of or active Pott's disease, stage \>4 renal disease 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.
* Has degenerative disc disease (DDD) related to a benign or malignant tumor.
* Has history or presence of active malignancy.
* Has known substance abuse, psychiatric disorder, or a 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.

Where this trial is running

Irvine, California and 5 other locations

• The Regents of the University of California- Irvine Campus — Irvine, California, United States (Recruiting)
• Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
• The Washington University — St Louis, Missouri, United States (Recruiting)
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Recruiting)
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Cesar Silva, MD

Conditions Degenerative Disc Disease; Spine Fusion; Back Pain