NCT07046000尚未招募不适用
Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft
Skye Biologics Holdings, LLC2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Graft Maturation via MRI
研究概览
简要总结
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
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
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL tear and reconstruction; no other knee ligaments needing reconstruction
- •Primary (first-time) ACL tear in the affected knee
- •ACL injury occurred less than 12 months before ACL reconstruction
- •Have no contraindications or allergies to the treatment administered
- •Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses
- •Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue
- •Able and willing to comply with the post-operative study follow-up schedule
排除标准
- •Prior surgery on the index knee within 12 months of enrollment
- •Steroid injection into the index knee within 6 weeks of enrollment
- •Chronic ACL tear whereas the injury occurred more than 12 months ago
- •Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed
- •Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)
- •Contraindication to MRI (eg, implanted devices incompatible with MRI).
- •Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery
- •History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher
- •History of malignant tumor and osseous metastatic disease,
- •History of chronic pain disorders (i.e., fibromyalgia),
- •Current substance abuse (drug or alcohol), by the investigator's judgment,
- •Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.
- •Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
- •Currently involved in any injury litigation or workers compensation claims,
- •Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
研究组 & 干预措施
ACL Reconstruction with Allograft
Subjects who have undergone ACL reconstruction with allograft
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Graft Maturation via MRI
时间窗: From 4.5 months post surgery until 12 months or graft maturation.
The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft
次要结局
未报告次要终点
研究者
研究点 (2)
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