CompletedNot Applicable

Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants

United States51 participantsStarted 2017-10-03

Plain-language summary

SALLY studies sacroiliac joint fusion with the iFuse-3D implant.

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient age 21-70 at time of screening.
✓. Patient has suspected SI joint pain for greater than or equal to 6 months inadequately responsive to conservative care.
✓. Diagnosis of sacroiliac joint dysfunction on one or two sides to be treated on study that is a direct result of sacroiliac joint disruption and/or degenerative sacroiliitis and is based on ALL of the following:
✓. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test) (on any targeted side), and
✓. Patient has positive findings on at least 3 physical examination maneuvers that stress the target SI joint(s) and
✓. Patient has block on any study targeted side with improvement in SI joint pain numeric rating scale (NRS) at 30 or 60 minutes of at least 50% after injection of local anesthetic into any affected SI joint with an immediate pre-block NRS of at least 5.
✓. Baseline Oswestry Disability Index (ODI) score of at least 30%.
✓. Baseline (average over the last week) SI joint pain score of at least 50 on 0-100 mm visual analog scale on any side to be treated under the study.

✕. Patient has bilateral SI joint symptoms with VAS pain scores ³50 on both sides and patient refuses to undergo bilateral treatment according to the study protocol.
✕. Patient is currently pregnant, actively trying to become pregnant or is planning to become pregnant in the next year.
✕. Severe back or hip pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar vertebral body fracture, piriformis syndrome, femoral acetabular impingement, labral tear or hip osteoarthritis. Patients with low back pain VAS ratings more than 50 should be carefully considered; they should not participate if the investigator believes these non-SIJ conditions would impair improvement from SIJ treatment.
✕. SI joint dysfunction due to an alternative explanation such as:
✕. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
✕. Tumor
✕. Infection
✕. Acute or unstable fracture.

Primary Radiographic Outcome: Bone adherence

Timeframe: Comparing 6 and 12 month CTs to historical data from other studies.

Primary Clinical Outcome: Disability due to low back pain

Timeframe: Comparing baseline to 6 months.

NCT IDNCT03122899

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-19

Who can participate

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient age 21-70 at time of screening.
✓. Patient has suspected SI joint pain for greater than or equal to 6 months inadequately responsive to conservative care.
✓. Diagnosis of sacroiliac joint dysfunction on one or two sides to be treated on study that is a direct result of sacroiliac joint disruption and/or degenerative sacroiliitis and is based on ALL of the following:
✓. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test) (on any targeted side), and
✓. Patient has positive findings on at least 3 physical examination maneuvers that stress the target SI joint(s) and
✓. Patient has block on any study targeted side with improvement in SI joint pain numeric rating scale (NRS) at 30 or 60 minutes of at least 50% after injection of local anesthetic into any affected SI joint with an immediate pre-block NRS of at least 5.
✓. Baseline Oswestry Disability Index (ODI) score of at least 30%.
✓. Baseline (average over the last week) SI joint pain score of at least 50 on 0-100 mm visual analog scale on any side to be treated under the study.

✕. Patient has bilateral SI joint symptoms with VAS pain scores ³50 on both sides and patient refuses to undergo bilateral treatment according to the study protocol.
✕. Patient is currently pregnant, actively trying to become pregnant or is planning to become pregnant in the next year.
✕. Severe back or hip pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar vertebral body fracture, piriformis syndrome, femoral acetabular impingement, labral tear or hip osteoarthritis. Patients with low back pain VAS ratings more than 50 should be carefully considered; they should not participate if the investigator believes these non-SIJ conditions would impair improvement from SIJ treatment.
✕. SI joint dysfunction due to an alternative explanation such as:
✕. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
✕. Tumor
✕. Infection
✕. Acute or unstable fracture.