NCT06311331Enrolling By Invitation不适用
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM): A Multicenter, Single Arm, Prospective, Post-approval Study for Patients Who Received the restor3d TTR Device to Evaluate Safety and Probable Benefit
Restor3D1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of participants who pass a composite of safety and probable benefit outcomes
研究概览
简要总结
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥22 Years of Age
- •Scheduled to receive TTR implant for one of the following indications:
- •Avascular necrosis of the talus
- •Avascular necrosis of the talus in addition to talar collapse, cysts or non-union
- •Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
- •Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments
- •Have not had a prior Total Talus Replacement device implanted
- •Not planning to receive bilateral Total Talus Replacement devices
- •Subject signs a written informed consent form (ICF) prior to the surgical procedure
排除标准
- •Surgical procedures other than those listed in the indications for use.
- •Use of implant greater than 6 months from date of patient's preoperative CT scan.
- •Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
- •Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane
- •Patients with an active local or systemic infection.
- •Osteonecrosis of the calcaneus, distal tibia or navicular.
- •Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
- •Blood supply limitations and previous infections that may prevent healing.
- •Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
- •Conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period.
- •Presence of neurological deficit which would prevent patient postoperative compliance.
- •Patients with foreign body sensitivity, suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.
结局指标
主要结局
Proportion of participants who pass a composite of safety and probable benefit outcomes
时间窗: At 5 years compared to baseline
The primary endpoint for this post approval study is a composite of safety and probable benefit. The safety endpoint is defined by the absence of device-related SAE and subsequent secondary surgical intervention (SSSI) on the affected joints. The probable benefit endpoint is defined as joint salvage with the restor3d device still in place. This composite endpoint will be evaluated by determining the proportion of patients who do not have a device-related SAE or SSSI, AND have the restor3d implant in place at 5 years.
次要结局
- Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline(At 5 years compared to baseline)
- Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline(At 5 years compared to baseline)
- Proportion of procedure-related Serious Adverse Events(At 5 years compared to baseline)
- Change in perceived pain from baseline(At 5 years compared to baseline)
- Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline(At 5 years compared to baseline)
- Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline(At 5 years compared to baseline)
- Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline(At 5 years compared to baseline)
- Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline(At 5 years compared to baseline)
- Change in ankle range of motion (ROM) from baseline(At 5 years compared to baseline)
- Proportion of Adverse Events(At 5 years compared to baseline)
研究者
研究点 (1)
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