Clinical trial NCT04218838: Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction
Official title: A Prospective, Multi-Center, Bi-Phasic Randomized Design to Compare Outcomes of the CornerLoc™ SI Joint Stabilization System and Intra-Articular Sacroiliac Joint Steroid Injection in Patients With Refractory Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sacroiliac Joint Somatic Dysfunction
Lead sponsor: CornerLoc
Sponsor class: INDUSTRY
First posted: 2020-01-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment.
Primary purpose: TREATMENT

Brief summary: This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.

Detailed description: Randomized, multicenter, open-label, randomized design to compare CornerLoc Allograft-based Sacroiliac Joint Stabilization System to Intra-articular Sacroiliac Joint Steroid Injection. Within the initial phase, referred to as the Randomized Phase, the primary determination of efficacy and safety will be 6-months following the study procedure. The analysis will be based on the randomization assignment. In the second phase of the study, referred to as the Cross-over Phase, patients who fail to respond to the randomized treatment assignment will be permitted to receive the non-randomized treatment. The basis of the sample size and hypothesis testing for this clinical investigation will be based on the Randomization Phase.

Eligibility criteria: Inclusion Criteria:

* Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:

  * Subject must provide written informed consent prior to any clinical study-related procedure.
  * Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
  * Subjects must meet criteria for sacroiliac joint dysfunction as determined below:
  * History of persistent pain in the distribution of the sacroiliac joint despite adequate trial of physical therapy.
  * NRS for pain ≥ 7 on a 0 -.10-point scale.
  * 3 of 5 provocative tests with positive findings on physical examination (SI distraction, thigh thrust, FABER, lateral compression, Gaenslen's maneuver).
  * Positive response (≥75% percent pain relief) to diagnostic sacroiliac joint injection on two occasions at least one week apart.
  * Baseline pain with 30-day history and PROMIS-29

Exclusion Criteria:

* Patient will not be entered into the study if they meet one of the following criteria:

  * Subject is unable to provide written informed consent
  * Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
  * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  * Subject had prior surgical fusion implanted on same side
  * Subject is pregnant or nursing
  * Self-reported plan to bear children
  * BMI ≥ 40
  * DEXA \< -2.5 (if available)
  * History of microfractures
  * History of compression fractures
  * History of diabetes, must have A1c \<8
  * History of chronic steroid use
  * Chronic immunosuppression

Primary outcomes:
measure: Efficacy of sacroiliac joint stabilization using the CornerLoc procedure in the treatment of sacroiliac joint pain by evaluating the efficacy responder rate versus an intra-articular steroid injection.
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life improvement from baseline to each follow-up visit.
timeFrame: 6 months
measure: Clinical improvement based on pain from baseline to each follow-up visit.
timeFrame: 6 months
measure: Clinical improvement of low back pain from baseline to each follow-up visit.
timeFrame: 6 months
measure: Clinical improvement in balance and risk for falls from baseline to each follow-up visit.
timeFrame: 6 months
measure: Clinical improvement from baseline to each follow-up visit.
timeFrame: 6 months
measure: Clinical improvement based on use of medications from baseline to each follow-up visit.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
Study officials:
affiliation: Center for Interventional Pain & Spine
name: Michael Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References: