Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- A change from Baseline in IKDC
研究概览
简要总结
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.
详细描述
OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.
28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.
Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:
- Posterior cruciate ligament (PCL)
- Anterior cruciate ligament (ACL)
- Posteromedial corner including the medial collateral ligament (MCL)
- Posterolateral corner including the lateral collateral ligament (LCL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female patients aged 18 years old or above.
- •Adults suffering with multiple knee ligament injuries.
- •Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.
排除标准
- •Those unable to give consent.
- •Those considered as conflicting variables by the investigator. This may include, but is not limited to:
- •Open trauma
- •Neurovascular emergencies
- •Compartment syndrome
- •Life threatening injury
- •Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
- •Associated fractures that require external fixators
- •Local severe concomitant injuries
- •Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient
- •Those considered as a poor candidate for surgery by the investigator.
- •If female and of child-bearing potential must not have a positive pregnancy test at Visit
- •1 nor have a stated intention to become pregnant in the next 12 months.
- •Those patients contraindicated for in the IFU, i.e.:
- •Showing signs of infection within 24 hours prior to surgery
- •Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material
- •Patients unable or unwilling to follow the post-operative care and rehabilitation programme
结局指标
主要结局
A change from Baseline in IKDC
时间窗: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
Assessment of knee stability via evaluation of IKDC score.
次要结局
- A change from Baseline in Lysholm(Baseline (30 days prior to surgery); 1, 3 ,6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up))
- A change from Baseline in KOOS(Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up))
- A change from Baseline in Assessment of Laxity via Physical Examination(Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up))