MagnetOs™ Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

NCT03625544 | Completed DMC

• 1 other identifier: NL64652.041.18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to demonstrate non-inferiority of MagnetOs™ Granules as an alternative to autologous bone graft in adult patients undergoing an instrumented posterolateral fusion of the thoracolumbar, lumbar or lumbosacral spine, in terms of efficacy and safety. After instrumentation and based on randomization, one side of the spine will be grafted with MagnetOs™ Granules and the other side with autologous bone graft. Thereby, each patient serves as its own control.

Conditions

Spinal Fusion

Keywords

bone graft; ceramic; spinal fusion; RCT

Outcome Measures

Primary Outcomes (2)

• Posterolateral spinal fusion rate at one-year follow-up

  For the efficacy analysis, a comparison will be made between the fusion performance of the MagnetOs™ Granules condition and the autograft condition after one year, assessed at CT-scans. Non-inferiority of MagnetOs™ Granules will be tested with a McNemar's test.

  1 year (12-15 months) after surgery

• Rate of (serious) adverse events that are related to the spinal fusion procedure in any way, and their potential relation with MagnetOs™ Granules.

  The safety of MagnetOs™ Granules will be evaluated by comparing the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure to rates in control populations from literature.

  Until 2 years (22-26 months) after surgery

Secondary Outcomes (6)

• Relation between successful posterolateral spinal fusion and interbody fusion at one-year follow-up

  1 year (12-15 months) after surgery

• Posterolateral spinal fusion rate at two years follow-up compared to the fusion rate at one-year follow-up

  2 years (22-26 months) after surgery

• Posterolateral spinal fusion rate of MagnetOs™ Granules compared to the results of AttraX® Putty from a previous study (AxA study)

  1 year (12-15 months) after surgery

• Relation between successful posterolateral spinal fusion and interbody fusion of MagnetOs™ Granules compared to the results of AttraX® Putty from a previous study (AxA study)

  1 year (12-15 months) after surgery

• Effect of blinding on perceived donor site pain

  Until 2 years (22-26 months) after surgery

Study Arms (2)

MagnetOs™ Granules

EXPERIMENTAL

MagnetOs™ Granules

Procedure: Instrumented posterolateral spinal fusion; Device: MagnetOs™ Granules

Autograft

ACTIVE COMPARATOR

Autologous bone graft

Procedure: Instrumented posterolateral spinal fusion; Procedure: Autologous bone graft

Interventions

Instrumented posterolateral spinal fusion PROCEDURE

Instrumented posterolateral spinal fusion, with or without an additional interbody device

Autograft; MagnetOs™ Granules

MagnetOs™ Granules DEVICE

8-10cc of MagnetOs™ Granules per spinal level at the randomized allocation side of the spine (left or right)

MagnetOs™ Granules

Autologous bone graft PROCEDURE

8-10cc autologous bone graft per spinal level at the control side of the spine (left or right). This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft.

Autograft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be treated with instrumented posterolateral thoracolumbar spinal fusion with the use of iliac crest bone, with or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected instability as a result of decompression for spinal stenosis;
• Deformity is defined as a scoliosis in the coronal plane of \>20° and/or a sagittal balance disturbance according the SRS/Schwab classification on standardized standing full spine radiographs;
• Preoperative instability is defined as a progressive angular deformity or spondylolisthesis in standing radiographs;
• Decompression for spinal stenosis is done in the occurrence of radiological evidence of stenosis on MRI and clinical leg and/or back pain with one or more of the following phenomena: radiculopathy, sensory deficit, motor weakness, reflex pathology or neurogenic claudication.
• Non-responsive to at least 6 months of non-operative treatment prior to study enrollment;
• Fusion indicated for one to six levels in the T10 to S2 region. In case of vertebral osteotomies (PSO or VCR) the osteotomized segment will not be included in the assessment of the fusion rate;
• Willing and able to understand and sign the study specific Patient Informed Consent;
• Skeletally mature between 18 and 80 years of age.

You may not qualify if:

• Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s);
• Previous treatments that compromise fusion surgery like irradiation;
• Previous autologous bone grafting procedures that compromise the quality and amount of iliac crest bone grafting;
• Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture;
• Active spinal and/or systemic infection;
• Spinal metastasis in the area intended for fusion;
• Systemic disease or condition, which would affect the subjects ability to participate in the study requirements or the ability to evaluate the efficacy of the graft (e.g. active malignancy, neuropathy, pregnancy);
• At risk to be non-compliant e.g.: (recently treated for) substance abuse, detainee, likely to immigrate
• Participation in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in this study;
• Female patients who intend to be pregnant within 1.5 year of enrollment in the study;
• Body mass index (BMI) larger than 36 (morbidly obese);
• Being expected to require additional surgery to the same spinal region within the next 6 months;
• Current or recent (\<1yr) corticosteroid use equivalent to prednisone ≥5mg/day, prescribed for more than 6 weeks.

Sponsors & Collaborators

• M.C. Kruyt, MD, PhD: lead
• Kuros BioSciences B.V.: collaborator

Study Sites (5)

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Links

• Publication of primary outcome

Study Officials

• Moyo Kruyt, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopaedic surgeon

Model Details: Intra-patient model, so each patient receives both conditions and serves as its own control

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 10, 2018
• Study Start: July 4, 2018
• Primary Completion: October 30, 2023
• Study Completion: October 7, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)