Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Comparison of Unilateral or Bilateral Fixation in the Treatment of LDD

Summary: TLIF is a popular lumbar interbody fusion technique to perform anterior interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, an open approach is required, using bilateral pedicle screw fixation to provide stability as the gold standard. However, the increased stiffness of the fused segments will reduce the bone mineral content in adjacent vertebrae, and biomechanical studies have indicated that increased stress at the levels adjacent to the fusion may increase adjacent segment pathology. Therefore, unilateral pedicle screw fixation had been considered as a means to decrease the stiffness of the instrumented segment. Recently, researchers have shown that unilateral instrumented spinal fusion provides comparable results and is as effective as bilateral fixation. In addition, the cost-effectiveness of this approach is worthy of attention. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar degenerative diseases using instrumented TLIF with unilateral or bilateral pedicle screw fixation.


Eligibility: Inclusion criteria:
  -  Signed informed consent.
  -  Patient is willing to be available for each examination scheduled over the study duration.
  -  Patient has symptom of low back pain with leg pain, tingling, numbness or weakness which obviously affect daily life and work;
  -  Lumbar DDD diagnosed using patient history and image-confirmation
  -  Has not responded to conservative treatment for a period of 6 months (e.g. bed rest, physical therapy, medication, manipulations, spinal injections, other).
  Exclusion Criteria:
  -  Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
  -  Has presence of active malignancy
  -  Has a history of severe allergy
  -  Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
  -  Pregnant, or may become pregnant within follow-up period of study
  -  Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
  -  Has undergone previous lumbar surgery
  -  Has severe osteoporosis (T-score ≤ -3.5)
  -  BMI > 35kg/m2
  -  Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
  -  Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)

Relevance to patient case: not relevant