跳至主要内容
临床试验/NCT04775004
NCT04775004进行中(未招募)不适用

Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)

University of Chicago3 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
146
试验地点
3
主要终点
Promis Physical function CAT lower extremity score

研究概览

简要总结

There are no current or past RCT comparing biologic augments for meniscal repair. There is good data supporting both the use of BMVP of the intercondylar notch and intra-articular PRP injections for augmentation of meniscal repair. However, the effectiveness of these augmentation methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this particular patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function as well as meniscal repair failure and reoperation rate.

The proposed interventional aim to compare meniscal repair augmentation methods is novel, as the direct comparison of these outcome measures has not been previously described. Because of the known benefit of biologic augmentation of meniscal repair, the investigators hypothesize that the repair failure rate for both cohorts will be lower than the reported repair failure rate for isolated tears without biologic augmentation; the investigators also hypothesize that BMVP of the intercondylar notch will clinically be significantly better than intra-articular PRP injection. The basis behind this hypothesis is in vivo evidence as well as a small RCT supporting the use of BMVP as augmentation for meniscal repair procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 16 or older
  • •Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
  • •Complex tears may be included at the discretion of the site investigator if patient has one of tear patterns listed in inclusion criteria 2 as the most predominant finding
  • •No other concomitant procedure unless one of the following:
  • •Chondroplasty
  • •Synovectomy
  • •Loose body removal
  • •"Contralateral" menisectomy (i.e. medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion
  • •Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure

排除标准

  • •Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
  • •Patients with meniscus root tears
  • •Patients undergoing repair for horizontal cleavage tears
  • •Kellgren-Lawrence scale 3>
  • •Patients undergoing lateral release
  • •Ipsilateral chondral lesion with Outerbridge classification of 3-4
  • •Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
  • •Cortisone use within the six weeks prior to surgery
  • •Utilizing worker's compensation at the time of screening
  • •Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
  • •Concomitant ligamentous insufficiency
  • •Inflammatory rheumatic disease or other rheumatic disease
  • •Immune compromised patients (hepatitis, HIV, etc.)
  • •Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
  • •History of distal femur, proximal tibia, or patellar fracture that was treated operatively
  • •Non English-speaking patients

研究组 & 干预措施

Bone marrow venting procedure (BMVP)

Active Comparator

Subjects randomized in the OR to undergo BMVP surgical augmentation

干预措施: Bone marrow venting procedure (BMVP) (Other)

Platelet rich plasma (PRP)

Active Comparator

Subjects randomized in the OR to undergo PRP surgical augmentation

干预措施: Platelet Rich Plasma (PRP) (Other)

结局指标

主要结局

Promis Physical function CAT lower extremity score

时间窗: 1-year after meniscus tear operation.

Adaptive questionnaire that takes five minutes or less to complete and helps record how subject injury and recovery from surgery is affecting their normal life.

次要结局

  • Re-tear of repair meniscus(1-year after meniscus tear operation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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