A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 22
- 主要终点
- Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months
研究概览
简要总结
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.
详细描述
This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure (SCP). Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion, such as a cyst or stress fracture confirmed by diagnostic imaging in the foot and/or ankle joint. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete validated patient reported outcomes measures pre-operatively including the Foot Function Index (FFI) revised short form, the EQ-5D™ and numeric pain score. These measures plus a subject satisfaction survey will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Screening for adverse events and revision surgeries will occur throughout the study.
Target enrollment is 140 patients at up to 25 clinical sites. Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Subject has at least one bone defect such as a bone marrow lesion (BML), cyst or stress fracture confirmed by diagnostic imaging
- •Surgeon considers the patient appropriate for the SCP procedure
- •Subject provides voluntary signature on the Institutional Review Board (IRB) approved Informed Consent
- •Subject is at least 18 years of age
- •Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail
排除标准
- •Subject is pregnant at the time of surgery
- •Subject is incarcerated
- •Subject is involved in active litigation related to the condition being treated
结局指标
主要结局
Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months
时间窗: 12 months
Change from baseline score, range 0-100, for patient reported pain, stiffness, difficulty, activity limitation and social issues at 12 months.
Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months
时间窗: 24 months
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
次要结局
- Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations(5 years)
- Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months(12 months)
- Change in numeric pain score from baseline at 12 Months(12 months)
- Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks(6 weeks postoperative)
- Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form(6 weeks postoperative)
- Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form(3 Months postoperative)
- Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)(1 year postoperative)
- Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form(6 Months postoperative)
- Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form(1 Year postoperative)
- Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)(12 weeks postoperative)
- Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)(3 months postoperative)
- Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)(6 months postoperative)
- Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)(2 years postoperative)
- Subject Quality-of-life at 6-weeks by the EQ-5D(6 weeks postoperative)
- Subject Quality-of-life at 3-months by the EQ-5D(3 months postoperative)
- Subject Quality-of-life at 6-months by the EQ-5D(6 months postoperative)
- Subject Quality-of-life at 1-year by the EQ-5D(1 year postoperative)
- Subject Quality-of-life at 2-years by the EQ-5D(2 year postoperative)