The primary objective is to demonstrate non-inferiority of MagnetOsTM Granules compared to autograft in instrumented posterolateral spinal fusion, in terms of efficacy and safety by means of an intra-patient model.
ID
Source
Brief title
Condition
- Joint disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy outcome is the rate of successful posterolateral spinal
fusion after one year, assessed on CT-scans. Non-inferiority of the MagnetOsTM
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 outcome
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 the AxA study.
Background summary
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, we completed enrollment and one-year
follow-up for a clinical trial to evaluate such a bone graft substitute (AxA
study, METC number 13-192). The product, AttraX® Putty, is a bioresorbable
tricalcium phosphate (TCP), mixed with a fast resorbing polymer carrier to
improve surgical handling. The preliminary results are promising in terms of no
adverse events related to the product and a first impression of similar fusion
rates. However, especially in more challenging conditions, both the autograft
and the material may resorb too fast and bone formation by induction was
limited. Recently an improved version of the TCP granules has been developed,
named MagnetOsTM Granules, which has shown favorable results especially of
these resorption and induction characteristics in pre-clinical studies.
MagnetOsTM Granules are CE-marked (2115660CE01) and received 510(k) clearance
from the US Food and Drug Administration (K161859).
Study objective
The primary objective is to demonstrate non-inferiority of MagnetOsTM Granules
compared to autograft in instrumented posterolateral spinal fusion, in terms of
efficacy and safety by means of an intra-patient model.
Study design
This study is designed as a multicenter, observer blinded, randomized,
controlled non-inferiority trial with intra-patient comparisons.
Intervention
According to a randomization scheme, one side of the spine will be grafted with
the MagnetOsTM 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.
Study burden and risks
Patient burden and risks are expected to be minimal. The first-year follow-up
will be according to the standard of care at the UMC Utrecht. Additional
procedures for this study include the completion of short patient reported
outcome measurements at five time points and, depending on the local follow-up
protocol, a CT-scan at one-year follow-up and/or X-ray at two years follow-up.
In case the one-year CT-scan shows a doubtful fusion or non-union in any of the
relevant levels, an additional CT-scan will be made at two years follow-up.
Based on pre-clinical investigations, and the results of the AxA study, the
risk for inferior performance of MagnetOsTM Granules is expected to be minimal.
Even if this appears to be the case, it will have minimal consequences for the
patient as the other side of the spine will be fused with autologous bone graft
and the spine is rigidly instrumented with screws and bars. All patients may
benefit from the study in terms of reduced surgical time, since only half of
the required bone graft will be harvested from the iliac crest.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64652.041.18 |