Clinical trial NCT04679844: Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Spine Fusion
Back Pain
Keywords: Degenerative Disc Disease
Spine Fusion
Lead sponsor: Kuros Biosurgery AG
Sponsor class: INDUSTRY
Collaborators: name: Simplified Clinical Data Systems, LLC
name: Kuros BioSciences B.V.
First posted: 2020-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-patient control. Each patient serves as their own control.
Primary purpose: TREATMENT

Brief summary: This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.

In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

Detailed description: In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local 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 30 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 Easypack Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Easypack Putty will be used standalone in patients up to two-level degenerative disc disease with segmental mechanical spinal instability requiring treatment 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, Discharge, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.

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.

Primary outcomes:
measure: Radiographic Fusion by CT Scan
timeFrame: Month 12
Secondary outcomes:
measure: Radiographic Fusion by Plain Radiographs
timeFrame: Month 6, Month 12
measure: Radiographic Fusion by CT Scan
timeFrame: Month 6
measure: Functional Outcome by Oswestry Disability Index Questionnaire
timeFrame: Screening, Week 2, Month 3, 6, and 12
measure: Back and Leg Pain by Visual Analog Pain Scale Questionnaire
timeFrame: Screening, Week 2, Month 3, 6, and 12
measure: Neurologic Status by Physical Exam
timeFrame: Screening, Week 2, Month 3, 6, and 12
measure: Success Rate
timeFrame: Week 2, Month 3, 6, and 12
Other outcomes:
measure: Safety Endpoint - number of patients with Adverse Events
timeFrame: 12 Months
measure: Safety Endpoint - number of patients with Serious Adverse Events
timeFrame: 12 Months
measure: Safety Endpoint - number of patients with Adverse Device Effects
timeFrame: 12 Months
measure: Safety Endpoint - number of patients with Device Related Complications
timeFrame: 12 Months
measure: Health Economic - Duration of Surgery
timeFrame: 12 Months
measure: Health Economic - Duration of Hospitalization
timeFrame: 12 Months
measure: Health Economic - Return to Work
timeFrame: 12 Months
Locations:
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Kuros BioSciences B.V.
name: Katherine Sage, DO
role: STUDY_DIRECTOR
References: