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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
CornerLoc SI Joint Stabilization Group
Patient will receive the CornerLoc minimally invasive SI Joint Stabilization procedure. This procedure will be performed in an outpatient surgery center under local sedation or general anesthesia, and normally takes around 45 minutes. During the procedure, the physician will make two small incisions in the patient's lower back to access the SI joint, and place four small cadaveric bone grafts into the SI joint to help stabilize the SI joint.
干预措施: CornerLoc SI Joint Stabilization Procedure (Device)
SI Joint Steroid Injections Group
Patient will receive an injection of steroid medication directly into their SI joint. The area around the SI joint will be numbed with an injection of local anesthetic and then ultrasound guidance will be used to guide the needle of steroid medication directly into the SI joint. This procedure will be performed in the physician's office or an outpatient surgery center, and normally takes around 30 minutes.
干预措施: Intra-articular Sacroiliac Joint Steroid Injection (Drug)
结局指标
主要结局
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.
时间窗: 6 months
The efficacy responder rate is defined as the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Numeric Rating Scale (NRS) for Pain, from Baseline to the 6-Month Visit. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- Quality of life improvement from baseline to each follow-up visit.(6 months)
- Clinical improvement of low back pain from baseline to each follow-up visit.(6 months)
- Clinical improvement in balance and risk for falls from baseline to each follow-up visit.(6 months)
- Clinical improvement from baseline to each follow-up visit.(6 months)
- Clinical improvement based on pain from baseline to each follow-up visit.(6 months)
- Clinical improvement based on use of medications from baseline to each follow-up visit.(6 months)