Clinical Study on a Novel Minimally Invasive Posterior Sa... | NCT04423120

NCT04423120

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Pacific Research Institute	NETWORK

Description Module

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters	A subject was considered a success if all of the following criteria were met 1. Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)	Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of device related serious adverse events	A subject was considered a success if all of the following criteria were met 2. Absence of device related serious adverse events, (Binary success failure composite end point)	Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of neurological worsening related to the lumbosacral nerve roots	A subject was considered a success if all of the following criteria were met 3. Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)	Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain	A subject was considered a success if all of the following criteria were met 4. Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)	Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.

Secondary Outcomes

Measure	Description	Time Frame
Change in VAS	1. Change in baseline in VAS from baseline at 6 months	Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in ODI

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 21-70
Patient has lower back pain for >6 months inadequately responsive to conservative care
Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint (FABER, Gaenslen test, Stork/Gillete, and Yoman)
Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) with confirmed arthrogram, within 30-60 min from injection
Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of prior lumbar fusion.
SIJ disruption was defined in the study of as SIJ mediated pain in the context of asymmetric widening of SIJ on CT or Xrays or the presence of significant contrast leakage during diagnostic SIJ block
Baseline Oswestry Disability Index (ODI) score of at least 30%
Baseline Low back/buttock pain score of at least 50 on 0-100 mm visual analog scale
Patient has signed study-specific informed consent form
Patient has the necessary mental capacity to consent and participate and is physically able to comply with study protocol requirements
Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
Patient's physician has decided that the best treatment for the patient's sacro-iliac disease is the LinQ system and the patient has agreed to the treatment.

Exclusion Criteria:

Inability to confirm that the pain is arising from the sacroiliac joint
Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal arthropathy.
Radicular pain extending beyond the buttock ≥ 30mm on VAS
Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or more
Has had an injection with corticosteroid into the index SIJ within the last 90 days
Has had any neuraxial injection with corticosteroid within the last 90 days
Has greater than 50% pain relief from diagnostic medial branch blocks at the L4/5 and/or L5/S1 levels
Has had a sacral radiofrequency ablation within the last 6 months
History of any hardware placement within the sacrum or sacroiliac joint
History of coccydynia or coccygectomy
Clinical diagnosis of discogenic pain at L4/5 and/or L5/S1
History of endometriosis or pudendal neuralgia
History of recent (<1 year) major trauma to pelvis
Chronic rheumatologic condition (e.g., rheumatoid arthritis)
Any condition or anatomy that makes treatment with the Linq Implant System infeasible
Use of medications known to have detrimental effects on bone quality and soft-tissue healing (metabolic bone disease, induced or idiopathic)
Prominent neurologic condition that would interfere with physical therapy
Current local or systemic infection that raises the risk of surgery
Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
Patient with insurance coverage that does not cover the SI fusion*
Implanted intrathecal pain pump

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms