适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Radiographic Evaluation
研究概览
简要总结
This study was designed to observe the outcomes of Pro Osteon according to its cleared indications for use.
详细描述
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of Pro Osteon® as a Bone Void Filler. FDA has cleared this device via premarket notifications 510(k) K063346, K980817, and K990131. There will be no experimental or investigational devices used.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will be the same as the stated indications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These indications are stated below:
- •PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
- •PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
- •Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection.
- •All patients must sign an IRB-approved Informed Consent to be enrolled into the study.
排除标准
- •Exclusion criteria will be the same as the stated contraindications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These contraindications are stated below:
- •Pro Osteon® 500R Resorbable Bone Graft Substitute is contraindicated for fractures of the growth plate
- •For segmental defects
- •For indications which may be subjected to excessive impact or stresses
- •When there is significant vascular impairment proximal to the graft site
- •When there are metabolic or systemic bone disorders that affect bone or wound healing
- •In infected sites
- •When stabilization of the defect is not possible.
- •The use of Pro Osteon® 500R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.
结局指标
主要结局
Radiographic Evaluation
时间窗: 3 Years
次要结局
- Knee Society Score(3 Years)
研究者
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