15-year survivorship analysis of an interspinous device in surgery for single-level lumbar disc herniation

Abstract

Background Interspinous devices have been introduced as alternatives to decompression or fusion in surgery for degenerative lumbar diseases. This study aimed to investigate 15-year survivorship and risk factors for reoperation of a Device for Intervertebral Assisted Motion (DIAM) in surgery for 1-level lumbar disc herniation (LDH). Methods A total of 94 patients (54 men and 40 women) underwent discectomy and DIAM implantation for 1-level LDH, with a mean follow-up of 12.9 years (range, 6.3–15.3 years). The mean age was 46.2 years (range, 21–65 years). Sixty-two patients underwent DIAM implantation for L4–5, 27 for L5–6, and 5 for L3–4. Reoperations due to any reason associated with DIAM implantation level or adjacent levels were defined as failure and used as the end point of determining survivorship. Results During the 15-year follow-up, 8 patients (4 men and 4 women) underwent reoperation due to recurrence of LDH at the DIAM implantation level, a reoperation rate of 8.5%. The mean time to reoperation was 6.5 years (range, 0.8–13.9 years). Kaplan-Meier analysis showed a cumulative survival rate of the DIAM implantation of 97% at 5 years, 93% at 10 years, and 92% at 15 years after surgery; the cumulative reoperation rate of the DIAM implantation was 3% at 5 years, 7% at 10 years, and 8% at 15 years after surgery. Mean survival time was predicted to be 14.5 years (95% CI, 13.97–15.07). The log-rank test and Cox proportional hazard model showed that age, sex, and location did not significantly affect the reoperation rate of DIAM implantation. Conclusions Our results showed that DIAM implantation significantly decreased reoperation rate for LDH in the 15-year survivorship analysis. We suggest that DIAM implantation could be considered a useful intermediate step procedure for LDH surgery. To the best of our knowledge, this is the longest follow-up study in which surgical outcomes of interspinous device surgery were reported.

Comparative Analysis of Early and Long-Term Outcomes of Patients with Degenerative Lumbar Spine Disease Using the DIAM Stabilizer and Standard Rehabilitation Program: A Preliminary Prospective Randomized Controlled Trial with 1-Year Follow-Up

“…Contraindications to surgical treatment and at the same time criteria for exclusion from the study were: (1) reduction in disc height > 60% at the involved level, (2) inflammation of the arachnoid membrane, (3) primary diagnosis of the cause of spinal discomfort other than DLSD in the involved segment, (4) DLSD requiring the surgical treatment of more than one level, (5) history of conservative treatment within 6 weeks before the planned surgery, (6) sequestration of herniated nucleus pulposus, (7) history of any surgery of the involved or adjacent level, (8) history of any intradiscal ablation procedure, (9) congenital or iatrogenic absence of posterior column elements (e.g., condition after resection of the intervertebral joint, spondylolysis, fracture, closed spina bifida), (10) underdevelopment or agenesis of the spinous process, (11) lower limb movement deficit, (12) cauda equina syndrome, (13) clinically significant peripheral neuropathy, ( 14) chronic ischemia of the lower extremities manifested by intermittent claudication, (15) history of traumatic fracture in L1-L5 segments, either compressive or with tearing, ( 16) lumbar scoliosis with a Cobb angle greater than 15 • , (17) established osteoporosis, osteopenia or osteomalacia, (18) obesity with a BMI of ≥40, (19) documented allergy to silicone, polyethylene, titanium or latex, (20) active bacterial infection, (21) active neoplastic disease or a history of neoplastic disease within the past 5 years including spinal neoplastic disease, (22) anesthetic contraindications to general anesthesia, and the lack of patients' informed consent.…”

“…Intradiscal procedures include chemonucleolysis, automatic percutaneous lumbar discectomy with nucleotome, percutaneous endoscopic discectomy, intradiscal endothermal therapy and laser disc decompression [19,20]. In the ever-growing array of surgical treatment options, one of the most commonly performed procedures today is interspinous stabilization with a dynamic-interspinous-stabilizer-type DIAM (device for intervertebral assisted motion) [21].…”

Biomechanical and clinical research of Isobar semi-rigid stabilization devices for lumbar degenerative diseases: a systematic review

“…It has also been argued that using PDS devices can improve fusion by allowing for micromovements between endplates and prevent against implant failure through improved load sharing [ 10 , 11 ]. So far, various PDS systems have been described in the literature, encompassing semi-rigid rod systems used primarily for fusion and tension band-based posterior systems generally used as no-fusion technologies [ 12 – 16 ].…”

An Investigation of Revisional Surgery After Implantation of Device for Intervertebral Motion (DIAM): A Case Series Study

“…During flexion, the DIAM™ device is an example of a lumbar device that decreases surgery complication motion at the implanted levels and the adjacent [13]. The long-term surgery complications of the DIAM™ device include higher reoperation, revision surgery, and higher cost-effectiveness [14]. This retrospective study evaluated the surgical outcomes and focused on the complications resulting from the long-term elevated intra-disk pressure that has been shown to be associated with the progression of lumbar disk degeneration.…”