Table S1.
Eligibility criteria for SIJ and SPORT studies
| SIJ studies |
| SIFI: NCT01640353 |
| INSITE: NCT01681004 |
| Inclusion criteria |
| 1. Age 21–70 years at time of screening |
| 2. Patient has lower back pain for >6 months inadequately responsive to conservative care |
| 3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following: |
| a) Patient has pain at or close to the posterior superior iliac spine with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test) |
| b) Patient has at least three of five physical examination maneuvers specific for the SIJ |
| c) Patient has improvement in lower back pain numeric rating scale of at least 50% after injection of local anesthetic into affected SIJ(s) |
| d) One or more of the following: |
| i. SIJ disruption: Asymmetric SIJ widening on X-ray or CT scan or leakage of contrast on diagnostic arthrography |
| ii. Degenerative sacroiliitis: Radiographic evidence of SIJ degeneration, including sclerosis, osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or due to prior lumbosacral spine fusion |
| 4. Baseline Oswestry Disability Index score of at least 30% |
| 5. Baseline SIJ pain score of at least 50 on 0–100 mm visual analog scale |
| 6. Patient has signed study-specific informed consent form |
| 7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements |
| Exclusion criteria |
| 1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture |
| 2. Other known sacroiliac pathology such as |
| a) Sacral dysplasia |
| b) Inflammatory sacroiliitis (eg, ankylosing spondylitis or other HLA-associated spondyloarthropathy) |
| c) Tumor |
| d) Infection |
| e) Acute fracture |
| f) Crystal arthropathy |
| 3. History of recent (<1 year) major trauma to pelvis |
| 4. Previously diagnosed osteoporosis (defined as prior T-score <−2.5 or history of osteoporotic fracture) |
| 5. Osteomalacia or other metabolic bone disease 6. Chronic rheumatologic condition (eg, rheumatoid arthritis) |
| 7. Any condition or anatomy that makes treatment with the iFuse Implant System® infeasible |
| 8. Chondropathy |
| 9. Known allergy to titanium or titanium alloys |
| 10. Use of medications known to have detrimental effects on bone quality and soft-tissue healing |
| 11. Prominent neurologic condition that would interfere with physical therapy |
| 12. Current local or systemic infection that raises the risk of surgery |
| 13. Patient currently receiving or seeking worker’s compensation, disability remuneration, and/or involved in injury litigation |
| 14. Currently pregnant or planning pregnancy in the next 2 years |
| 15. Patient is a prisoner or a ward of the state |
| 16. Known or suspected drug or alcohol abuse |
| 17. Diagnosed psychiatric disease (eg, schizophrenia, major depression, personality disorders) that could interfere with study participation |
| 18. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation |
| SPORT, Intervertebral Disc Herniation: NCT00000410 |
| Inclusion criteria |
| 1. Duration of symptoms: 6 or more weeks |
| 2. Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy |
| 3. Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising |
| 4. Tests: MRI to confirm diagnosis and level(s) |
| Exclusion criteria |
| 1. Previous lumbar spine surgery |
| 2. Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months |
| 3. Possible pregnancy |
| 4. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years |
| 5. Current fracture, infection, and/or deformity (greater than 15° of lumbar scoliosis, using Cobb measure technique) of the spine |
| 6. Age less than 18 years |
| 7. Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery) |
| 8. Unavailability for follow-up (planning to move, no telephone, etc) or inability to complete data surveys |
| 9. Symptoms less than 6 weeks |
| 10. Patient currently enrolled in any experimental “spine-related” study |
| SPORT, Degenerative Spondylolisthesis: NCT00000409 |
| Inclusion criteria |
| 1. Duration of symptoms: 12 or more weeks |
| 2. Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy |
| 3. Surgical screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms |
| 4. Tests: MRI to confirm diagnosis and level(s) |
| Exclusion criteria |
| 1. Previous lumbar spine surgery |
| 2. Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months |
| 3. Possible pregnancy |
| 4. Active malignancy: Patients with a history of any invasive malignancy (except non-melanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years |
| 5. Current fracture, infection, and/or deformity (greater than 15° of lumbar scoliosis, using Cobb measure technique) of the spine |
| 6. Age less than 18 years |
| 7. Cauda Equina syndrome or progressive neurologic deficit (usually requiring urgent surgery) |
| 8. Unavailability for follow-up (planning to move, no telephone, etc) or inability to complete data surveys |
| 9. Symptoms less than 12 weeks |
| 10. Patient currently enrolled in any experimental “spine-related” study |
| SPORT, Spinal Stenosis: NCT00000411 |
| Inclusion criteria |
| 1. Duration of symptoms: 12 or more weeks |
| 2. Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy |
| 3. Surgical screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms |
| 4. Tests: MRI to confirm diagnosis and level(s) |
| Exclusion criteria |
| 1. Previous lumbar spine surgery |
| 2. Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months |
| 3. Possible pregnancy |
| 4. Active malignancy: Patients with a history of any invasive malignancy (except non-melanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years |
| 5. Current fracture, infection, and/or deformity (greater than 15° of lumbar scoliosis, using Cobb measure technique) of the spine |
| 6. Age less than 18 years |
| 7. Cauda Equina syndrome or progressive neurologic deficit (usually requiring urgent surgery) |
| 8. Unavailability for follow-up (planning to move, no telephone, etc) or inability to complete data surveys |
| 9. Symptoms less than 12 weeks |
| 10. Patient currently enrolled in any experimental “spine-related” study |
Abbreviations: CT, computed comography; HLA, human leukocyte antigen; INSITE, Investigation of Sacroiliac Fusion Treatment; MRI, magnetic resonance imaging; SIFI, Sacroiliac Joint Fusion with iFuse Implant System®; SIJ, sacroiliac joint; SPORT, Spine Patient Outcomes Research Trial.