Clinical trial: Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine (NCT01323543)

Eligibility criteria:
Inclusion Criteria:

          1. Patient has signed and understood the approved Informed Consent form and is able to
             meet the proposed follow-up and postoperative management program.

          2. Patient is skeletally mature and between 21 - 80 years of age.

          3. Patient's pre-operative Body Mass Index (BMI) is ≤ 34.

          4. Patient's pre-operative Oswestry Disability Index (ODI) is ≥ 30% (≥15 out of 50
             points).

          5. Patient's pre-operative back pain Visual Analogue Scale (VAS) is >60 (0-100 scale),
             with or without associated leg pain (leg pain VAS score).

          6. Patient has received non-operative treatment for low back pain for > 6 months and is
             unresponsive.

          7. Patient has one or more of the following structural abnormalities with imaging studies
             verifying them at one or two contiguous levels within L1-L5:

               -  Discopathy

               -  Degenerative disc disease

               -  Massive or recurrent disc herniation

               -  Non-isthmic spondylolisthesis ≤ Grade 1 (acc. To Meyerding)

               -  Spinal stenosis

               -  Partially defective facet joints

               -  Retrolisthesis according to one of the following definitions (acc. to Ruch,
                  William J.; Literature Reference 21):

                    -  Complete Retrolisthesis: The body of one vertebra is posterior to both the
                       vertebral body of the segment of the spine above as well as below

                    -  Stairstepped Retrolisthesis: The body of one vertebra is posterior to the
                       body of the spinal segment above, but is anterior to the one below.

                    -  Partial Retrolisthesis: The body of one vertebra is posterior to the body of
                       the spinal segment either above or below.

        Exclusion Criteria:

          1. Degenerative spondylolisthesis greater than Grade 1 as defined by greater than 25
             percent vertebral slip forward over the inferior vertebral body (acc. to Meyerding
             Classification) or significant segmental instability at or adjacent to intended
             treatment level.

          2. Need for more than two-level or two non-contiguous-level surgery in the lumbar spine.

          3. Patient has more than 50% defective facet joint (half of the articular joint surface)
             or laminectomy

          4. Patient is scheduled for another lumbar surgery such as but not limited to a fusion

          5. Patient has recent vertebral fractures or past fractures which did not heal.

          6. Patient has known allergies to titanium alloy and polycarbonate urethane (PCU).

          7. Patient has clinically compromised vertebral body structure and morphology at the
             lumbar spine due to current or past trauma (or pathological vertebral fracture) or
             significant endplate incompetence such as Schmorl´s node.

          8. Patient has spondylolysis at the levels to be treated or an adjacent level.

          9. Patient has a frontal curve in the lumbar spine >10°.

         10. Patient has previously been diagnosed osteopenia or metabolic bone diseases or severe
             osteoporosis - if suspected to be confirmed by bone density being 2.5 SD below normal
             as assessed using DEXA analysis in:

               -  Postmenopausal females if suggested by x-ray or other risk factors

               -  Males over the age of 60 that have sustained a non-traumatic hip or spine
                  fracture

         11. Patient is taking medications known to potentially interfere with bone/soft tissue
             healing, including but not limited to the long term use of corticosteroids. (This is
             not intended to exclude patients using inhalation medications for asthma.)

         12. Patient has an active infection either systemic or at the local site of intended
             surgery.

         13. Patient has been diagnosed with hepatitis, rheumatoid arthritis, an autoimmune
             disease, or AIDS, ARC, or is HIV positive or any other diseases that according to
             surgeons may have an impact on the outcome of the surgery.

         14. Patients with known malignant diseases or bone tumors.

         15. Patients with vascular malformations such as abdominal aneurysm.

         16. Patient has a progressive neuromuscular disease. Patient has active malignancy within
             the last 15 years, unless the malignancy was treated with curative intent and there
             have been no clinical signs or symptoms for at least 5 years.

         17. Patient has cervical myelopathy.

         18. Patient is pregnant or planning in becoming pregnant in the next 2 years.

         19. Patient is currently participating in another investigational study where the
             endpoints have not yet been achieved. 8/35 Elaspine™ PMCS 01, Clinical Investigation
             Plan CIP EN Version C, October 1st, 2010 CONFIDENTIAL

         20. Patient has mental illness, and/or diagnosed as clinically depressed or belongs to a
             vulnerable population (e.g., prisoner, severe drug abuser, developmentally disabled)
             that would compromise ability to provide informed consent or compliance with follow-up
             requirements. If suspected to be confirmed by classification according to DSM IV.

         21. Patient has had another surgical procedure(s) within the last 60 days involving
             general anesthesia or any surgical procedure that might increase the risk of deep vein
             thrombosis.

         22. Loss of Disk height according to Pfirrmann (> C) or Frymoyer (>3) and or severe
             spondylosis.

         23. Patient shows three or more signs of anorganic behaviour (Waddell´s signs).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? 0