The primary objective of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.
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 outcomes of this study are the posterior spinal fusion rate after
one year (based on CT-scans), and the complication rate and potential relation
of (serious) adverse events with AttraX® Putty.
Secondary outcome
Secondary outcomes are the resorption characteristics during the first year,
volume of bridging bone mass after one year, evaluation of iliac crest pain,
correlation of the posterior fusion rate to the presence of interbody fusion
after one year and the posterior spinal fusion rate after two years.
Background summary
Spinal fusion, a surgical procedure frequently used for many spinal conditions
requiring stabilization of the vertebral column, is currently performed by
using large amounts of autologous bone graft or autograft. A substitute for
this patient own bone would eliminate the graft harvesting morbidity that is
currently one of the main disadvantages. Recently, a promising synthetic graft
substitute has been developed that has shown favorable results in pre-clinical
studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium
phosphate (TCP), mixed with a fast resorbing polymer carrier to improve
surgical handling.
Study objective
The primary objective of this study is to demonstrate the non-inferiority of
AttraX® Putty as a bone graft substitute for autograft in instrumented
posterolateral fusion of the thoracolumbar spine, in terms of efficacy and
safety.
Study design
This study is designed as a patient and observer blinded, controlled,
randomized, multi-center clinical trial with intra-patient comparisons. This
means that each patient is it owns control.
Intervention
According to a randomization scheme, one side of the spine will be grafted with
the synthetic ceramic material AttraX® Putty instead of bone harvest from the
iliac crest which is currently the gold standard. 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 standard care. Additional procedures for this study
include the completion of short patient reported outcome measurements at each
regular visit to the clinic and a CT-scan after two years in a subset of the
patients. In addition, extra DEXA-scans will be made of 32 patients at each
regular follow-up visit. Based on pre-clinical investigations, the risk for
inferior performance of AttraX® Putty 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 bone graft morbidity, 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 or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected or potential instability, for example as a result of decompression for spinal stenosis or benign lesions;
1. Deformity is defined as a scoliosis in the coronal plane of >20° and/or a sagittal balance disturbance according the SRS classification on standardized standing full spine radiographs;
2. Preoperative instability is defined as >2mm translation 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 or more levels in the T10 to S1/ilium region;
* 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);
* 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 a traumatic reason, like a spinal fracture or traumatic instability;
* 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);
* 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 the study;
* Female patients who intend to be pregnant within 1.5 year of enrollment in the study;
* Body mass index (BMI) larger than 35 (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 | NL44095.041.13 |