Disc degeneration or spinal deformity in the lumbosacral vertebra (L2-S1)
Conditions
Interventions
Subjects will be randomly assigned 1:1 to the following two groups:
- MDT-0123 group (clinical trial group): Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.
- ICBG group (control gr
Sponsors
Shiomitsu Aki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who require bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity etc in the lumbosacral vertebrae (L2-S1). 2) Subjects who satisfies any of the following. 1. Image findings of symptomatic degenerative lesions from L2 to S1 (MRI or myelography within 12 months prior to enrollment) and subjects who have been observed to have any of the neurological disorders by nerve root compression etc. as follows. A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness B) Nervous claudication * If the subject has not had an MRI or contrast-enhanced imaging study in the past 12 months, the subject must have an MRI or contrast-enhanced imaging study. 2. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc conformed by subject history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution ], function deflect and/or neurological deficit and radiographic studies (e.g., CT, MRI, X-Ray, etc.) to include one or more of the following: A) Instability (defined as angular motion >=5 and/or translation >=4mm, based on radiographs of anteroposterior flexion). B) Formation of osteophytes C) Decrease in the height of the intervertebral disc D) Thickening of ligamentous tissue E) Degeneration or herniation of the disc F) Degeneration of facet joints 3) Subjects with a preoperative ODI score of 35% or greater. 4) Subjects with sufficiently mature skeletons. 5) Subjects who are 18 to 80 years of age at the time of surgery. 6) Subjects who has not responded to non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, percutaneous electrical stimulation therapy (TENS)) for a period of 3 months. 7) Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.
Exclusion criteria
Exclusion criteria: 1) Has undergone previous spinal surgery at the intervertebral level in question or at an adjacent spinal level. (e.g., spinal surgery other than spinal fusion or spinal fusion). Furthermore, the history of surgeries aimed for decompression or relief, such as discectomy and/or discectomy surgery is acceptable. 2) Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure. 3) Those whose total rhBMP-2 implantation is expected to exceed 12 mg. 4) Subjects for whom use of an internal or external bone growth stimulator is planned. 5) Subjects who have been diagnosed with osteoporosis with a T-score of -2.5 or lower within the past 12 months and who also present with fragility fractures at the time of informed consent. If the subject has a history of fragility fracture and the T score has not been assessed within the past 12 months, the subject must receive undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA). 6) Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40. 7) Subjects with an active malignancy. 8) Overt or active bacterial infection, either local to surgical space or systemic 9) Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device. 10) Subjects who have been administered corticosteroids, anti-tumor drugs, immune stimulators, immunosuppressants, or systematic drugs that may interfere with the treatment of bone or soft tissue within 30 days prior to implantation of the investigational device. - All other patients who are taking Warfarin must have a washout for at least 5 days prior to the index procedure. - Steroid inhalers and topical steroids can be used before and after surgery. - Use of short-term steroids before and after surgery is permissible. In this clinical trial, short-term use is defined as 2 weeks or less. Steroid use that exceeds consecutive 2 weeks postoperatively is prohibited until the follow-up examination 12 months later. 11) Subjects with a medical history of autoimmune diseases known to affect bone metabolism or the spine. Examples include spondylotic arthropathy (e.g., ankylosing spondylitis, Crohns disease, ulcerative colitis), juvenile arthritis, rheumatism, Graves' disease, and Hashimoto's disease. 12) Subjects with a medical history of endocrinological or metabolic diseases known to affect bone formation (e.g., Paget disease, nephrogenic osteodystrophy, Glas-Danlos syndrome, and osteogenic dysplasia). 13) Subjects who have a history of exposure to a modified protein used for bone formation. 14) Bone morphogenic proteins (BMPs) (BMP agents were used for dental treatment, etc.), injection collagen, protein drugs (monoclonal antibodies, gamma globulin, etc.), bovine collagen Subjects who have a medical history of hypersensitivity, allergy, or intolerance to the device and/or instrument materials (titanium alloy). 15) Subjects with a medical history of allergy that may cause anaphylaxis. 16) Subjects who have a mental disorder and have been judged by the investigator or the investigator to be of an inappropriate level for enrollment into this clinical trial. 17) Subjects who have received treatment in other clinical trials for spinal disease within 3 months prior to the index procedure (drugs, equipment, and/or biological products), subjects who have received treatment in other clinical trials within 28 days prior to the index procedur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints of efficacy: Bone fusion success status at 12 months visit after index procedure The success rate of bone fusion at the 12-month visit after the index procedure will be evaluated. Imaging evaluations will be performed at baseline, after the index procedure (to discharge), at 6weeks and 3, 6, 12 months (CT scan will be performed at 6, and 12 months only), and imaging evaluation for the primary efficacy endpoint will be performed by the core laboratory at the 12-month visit. Primary endpoints of safety: Adverse Device Effects up to 12 months post index procedure Events that are related to index procedure, to MDT-0123 Spinal cage, to intervertebral body grafting material and to Posterior Supplemental Fixation are considered Adverse Device Effects. To evaluate the rate of subjects experiencing any adverse device effects in both groups that occur up to 12-month visit after the index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical data related to secondary endpoints will be collected at baseline (except for disc height and time to fusion), 6 weeks, 3 months, 6 months, and 12 months to determine changes over time. The following is a list of secondary endpoints, which will be evaluated and compared between the two groups. 1 Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure; The height of the intervertebral disc measured by x-ray in the standing position. The calculation method uses (anterior disc height + central disc height + posterior disc height) divided by the anteroposterior diameter of the vertebral body. Preoperative measurements are conducted to understand the subjects pathological condition. 2 Change of General health conditions from baseline at month 12; General health condition of subjects was evaluated using the Medical Outcomes Study 36-ltem Short Form Health Survey (SF-36). The SF-36 results can be summarized into two components: a physical component summary (PCS) and a mental component summary (MCS). 3 Change of OSWESTRY DISABILITY INDEX (ODI) from baseline at month 12; Using ODI, calculate each score from the 10 sections (pain intensity, self-care, lifting, etc.) 4 Change of Lower back pain from baseline at month 12; The level of lower back pain was evaluated using the numerical rating scale (Numerical Rating Scale (NRS)) on a scale of 11. 5 Change of Leg pain from baseline at month 12; The level of pain in the lower limbs was evaluated on a scale of 11 using the numerical evaluation scale (NRS). 6 Time required for bone fusion Image evaluation (CT examination, X-ray examination) to evaluate the required time until bone fusion. | — |
Contacts
Public ContactAki Shiomitsu
Medtronic Sofamor Danek Co., Ltd.
Outcome results
None listed