Clinical Trial Finder

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.

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 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.

• - Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.

• - 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.

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and demineralized bone matrix mixed with autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients up to two-level degenerative disc disease with up to grade 1 spondylolisthesis requiring treatment or spinal trauma with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Day 0, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.

Arms

Experimental: MagnetOs Putty

Interventions Procedure: Instrumented posterolateral spine fusion Device; MagnetOs Putty

Active Comparator: Demineralized Bone Matrix mixed with Autograft Bone

Interventions Procedure: Instrumented posterolateral spine fusion Device: Demineralized Bone Matrix mixed with Autograft Bone

Interventions

Device: - MagnetOs Putty

MagnetOs Putty use in instrumented posterolateral fusion, 5cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side.

Device: - Demineralized Bone Matrix mixed with Autograft Bone

Demineralized Bone Matrix mixed with Autologous bone graft used in instrumented posterolateral fusion, 5cc-10cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.