MedDataX Logo

MagnetOs™ Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

NCT ID: NCT03625544

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2024-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Posterolateral spinal fusion is currently performed by using large amounts of autologous bone graft. Drawbacks of bone grafting include the need for an additional surgical procedure, limited supply, sub-optimal bone quality in osteoporotic patients and harvesting morbidity, which led to the development of numerous bone graft substitutes. Recently, a promising synthetic graft substitute has been developed that has shown favorable results in pre-clinical studies. This product, MagnetOs™ Granules, is CE-marked and received 510(k) clearance from the US Food and Drug Administration. The aim of the current study is to demonstrate non-inferiority of MagnetOs™ Granules compared to autograft in instrumented posterolateral spinal fusion, in terms of efficacy and safety.

This study is designed as a multicenter, observer blinded, randomized, controlled non-inferiority trial with intra-patient comparisons. A total of 100 adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will be recruited and enrolled. According to a randomization scheme, one side of the spine will be grafted with the MagnetOs™ Granules and the other side with bone harvested from the iliac crest and local bone. The rest of the surgical procedure will be according to standard care.

The primary efficacy outcome is the rate of successful posterolateral spinal fusion after one year, assessed on CT-scans. Non-inferiority of the MagnetOs™ condition compared to the autograft condition will be assessed using a McNemar's test. The primary safety outcome is the number and nature of (serious) adverse events related to the surgical procedure compared to control populations from literature. Secondary outcomes are the comparison to its predicate (AttraX® Putty), relation between posterolateral fusion and interbody fusion after one-year, posterolateral spinal fusion rate after two years, relevance of iliac crest donor site pain and the incidence of long-term complication and relation with risk factors in the combined population of this study and a recently completed clinical trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Fusion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bone graft ceramic spinal fusion RCT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intra-patient model, so each patient receives both conditions and serves as its own control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MagnetOs™ Granules

MagnetOs™ Granules

Group Type EXPERIMENTAL

Instrumented posterolateral spinal fusion

Intervention Type PROCEDURE

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

MagnetOs™ Granules

Intervention Type DEVICE

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

Autograft

Autologous bone graft

Group Type ACTIVE_COMPARATOR

Instrumented posterolateral spinal fusion

Intervention Type PROCEDURE

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

Autologous bone graft

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Instrumented posterolateral spinal fusion

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

Intervention Type PROCEDURE

MagnetOs™ Granules

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

Intervention Type DEVICE

Autologous bone graft

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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;

1. 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;
2. Preoperative instability is defined as a progressive angular deformity or spondylolisthesis in standing radiographs;
3. 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kuros BioSciences B.V.

INDUSTRY

Sponsor Role collaborator

M.C. Kruyt, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M.C. Kruyt, MD, PhD

Orthopaedic surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Moyo Kruyt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status

Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://journals.lww.com/spinejournal/fulltext/2024/10010/efficacy_of_biphasic_calcium_phosphate_ceramic.1.aspx

Publication of primary outcome

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL64652.041.18

Identifier Type: -

Identifier Source: org_study_id