Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02087267
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic degenerative disc disease or degenerative spondylolisthesis grade 1 or 2 with chronic low back pain, pain in the leg or buttock, muscle weakness, sensation abnormalities and/or neurogenic claudication
* Unsuccessful adequate conservative treatment
* 1- or 2- contiguous level lumbar spinal fusion between L2 and S1 with posterior instrumentation in combination with Transforaminal Lumbar Interbody Fusion (TLIF)
* Age between 18 - 80 years at the time of surgery
* Skeletally mature patient
* Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and imaging evaluations and the prescribed rehabilitation
* Patient signed Informed Consent
Exclusion Criteria:
* No adequate non-operative care prior to being treated with a lumbar fusion device
* 3-level fusion or more
* Fusion not between L2 and S1
* Previous lumbar spinal surgery, other than discectomy at the level(s) to be operated on
* Spondylolisthesis acc. to Meyerding grade 3 or higher
* Transforaminal access to the disc space is obstructed
* Use of bone grafts other than autologous grafts, demineralized bone matrix without additional growth factors and synthetic bone substitute without additional growth factors. Growth factor enhanced grafts, cement or any other graft material are excluded.
* Adiposity, severe obesity (BMI \> 35 kg/m2)
* Any contraindication for MRI scan including heart pacemaker, metallic foreign body (metal sliver) in the eye or brain, aneurysm clip in the brain, severe claustrophobia etc.
* Discitis, spondylodiscitis
* Acute or chronic infection, previous surgical site infection or severe defect of the osseous structures
* Open wounds
* Patient who takes immunosuppressive or long-term steroid use
* Fever
* Allergy or intolerance to any device material (e.g. Carbon/PEEK, titanium or tantalum)
* Foreign body sensitivity
* Insufficient form fit between the implant and the bone owing to deformation or destruction of the pedicles or of the vertebral body end plates
* Risk that the intervertebral device can subside into the vertebral bodies
* Bone tumors in the region of the implant anchoring
* Severe osteoporosis or similar bone density loss, incl. any metabolic bone disease
* Cases, in which the progression of degenerative disease is so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance
* Systemic or metabolic illnesses (i.e. insulin-dependent diabetes)
* Patient who is suffering from rheumatological or other inflammatory joint disease
* Paralysis of lower extremity
* Generally poor condition of the patient
* Psychosocial issues; lack of co-operation by the patient
* Drug abuse or alcoholism
* Any medical or surgical condition that could preclude the potential success of the implantation
* Any condition not described in the indications for use
* Unwillingness or inability of the patient to follow the instructions for postoperative treatment or with the follow-up evaluation schedule
* Female patient who is pregnant or plans to become pregnant during the course of the study
* Prisoner
* Patient who has not signed the Informed Consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02087267
Study Brief:
Protocol Section:
NCT02087267