Active — Not RecruitingNot Applicable

Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain

Norway, Sweden63 participantsStarted 2018-06-08

Plain-language summary

Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.

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.

✓. Age 21-70 at time of screening
✓. Patient with suspected SIJ pain for \>6 months or \>18 months for pregnancy induced pelvic girdle pain.
✓. Diagnosis of the SI joint as the primary pain generator based on ALL of the following:
✓. Compression
✓. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)
✓. Palpation of the long dorsal ligament
✓. Patrick's test (Faber)
✓. Leg Raise (ASLR )

✕. Severe low 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.
✕. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
✕. History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
✕. Spine surgery during the past 12 months.
✕. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
✕. Documented osteomalacia or other metabolic bone disease
✕. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
✕. Patients with prior successful fusion to the contra lateral side are exluded from the study.

Primary outcome measure - Numeric Rating Scale operated side

Timeframe: 6 months

NCT IDNCT03507049

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-25

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.

✓. Age 21-70 at time of screening
✓. Patient with suspected SIJ pain for \>6 months or \>18 months for pregnancy induced pelvic girdle pain.
✓. Diagnosis of the SI joint as the primary pain generator based on ALL of the following:
✓. Compression
✓. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)
✓. Palpation of the long dorsal ligament
✓. Patrick's test (Faber)
✓. Leg Raise (ASLR )

✕. Severe low 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.
✕. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
✕. History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
✕. Spine surgery during the past 12 months.
✕. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
✕. Documented osteomalacia or other metabolic bone disease
✕. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
✕. Patients with prior successful fusion to the contra lateral side are exluded from the study.