Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Prevention of additional surgery into the target knee
研究概览
简要总结
The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).
详细描述
The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution.
The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand, sign and complete informed consent
- •Male or female subject between the ages of 18-60 years
- •Subject has had pain for greater than three months
- •Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
- •Subject has stable ligaments
- •Subject has neutral alignment (max 5° varus or valgus)
- •Subject has a VAS score greater than or equal to five
- •Subject is scheduled to undergo surgical intervention using IOBP®
排除标准
- •Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
- •Subject has had lower extremity surgery within six months
- •Subject has had more than two prior surgical procedures in the operative leg
- •Subject has a neuromuscular condition
- •Subject has a current infection
- •Subject has a BMI >35
- •Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
- •Subject has joint surface collapse in late stage avascular necrosis
- •Subject has majority of pain associated with alternate conditions
- •Subject has had subchondral bone pathology caused by acute trauma
- •Subject is not neurologically intact.
- •Subject has history of invasive malignancy (except non-melanoma skin cancer)
- •Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
- •Subject has an active substance abuse problem
- •Subject is currently taking narcotic pain medication
- •Subject is pregnant or planning to become pregnant
- •Subject is on worker's compensation
- •Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
- •Inability to complete study requirements and follow-up visits
- •Subject that has a bone marrow aspiration that does not meet 60cc
结局指标
主要结局
Prevention of additional surgery into the target knee
时间窗: 5 years
To evaluate if IOBP® procedure will prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.
次要结局
- MRI of the knee(6 months and 1 year)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op)
- International Knee Documentation Committee Subjective Knee Evaluation Form(knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.)
- Visual Analog Pain Scale (VAS)(Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op.)
- X-rays of the knee(6 months and 1 year)