The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:
* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain. * To evaluate if implantation causes significant increase quality of life of the patients. * To evaluate if using the device can be considered as safe overall.
Low back pain, or
Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or
History of neurogenic claudication.
Instability as defined by ≥3 mm translation or ≥5-degree angulation
Prior surgical procedure at the involved or adjacent spinal levels (e.g. stabilization, fusion, arthroplasty and/or other non-fusion procedures). Prior microdiscectomy, discectomy, laminectomy, decompression surgery at the target or adjacent levels is allowed.
Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
Planned use of an internal or external bone growth stimulator.
Lumbar scoliosis >30 degrees.
Single group
ReSpace TiCell Cage
DeviceReSpace TiCell Cages are anatomically shaped interbody spacer implants with curved contour. These implants intended to be inserted into the intervertebral disc space for intervertebral body fusion. The interbody spacers are designed to restore height and lordotic angle in the spine. The spacers have teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity on them allows for placement of graft material allowing for subsequent bone growth through the interior of the devices. ReSpace TiCell Cages are indicated for lumbar spine stabilization (between L.I.-S.I. segments). TLIF spine surgery will be combined with posterior fixation using pedicle screws and rods.
CT imaging_1 - cumulative fusion rate
For the determination of the cumulative fusion rate, radiographic evaluation (CT imaging with fine-cut axial and multiplanar reconstruction views) will be conducted by 2 independent examiners.
CT imaging_2 - fusion status
Standing flexion-extension angle will be measured with dynamic plain radiography to evaluate mobility to determine the fusion status.
Visual Analog Scale
The severity of back, hip/buttock, and leg pain will each be evaluated in all study subjects using a 100-mm Visual Analog Scale (VAS). Minimum value is 0mm, maximum value is 100mm. The low value means low intensity of the pain, which is the aim of the treatment.
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) is a validated, independent outcome measure. It is one of the principal condition-specific outcome measures used in the management of spinal disorders and in patients with low back pain. The questionnaire contains 10 questions. There are 6 possible answers available to each questions. The 1. answer means each time the lowest pain, which is the aim of the treatment. At the end the doctor calculate a rate of the patient pain in %.
AE and ADE
To prove the safe and effective use of the medical device. Number of patients with Adverse Events (AE) and Adverse Device Effects (ADE) are administered and observed during the study.
Complications
To prove the safe and effective use of the medical device. The rate of complications is administered and observed during the study.
Surgical revisions
To prove the safe and effective use of the medical device. The rate of surgical revisions is administered and observed during the study.
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