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临床试验/NCT05053646
NCT05053646招募中不适用

Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial

Christian Candrian3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
3
主要终点
subjective International Knee Documentation Committee (IKDC) score

研究概览

简要总结

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of meniscal repair, allowing the patient a better recovery.

详细描述

Meniscal tears are one of the most common lesions of the knee and are a risk factor for the development of knee osteoarthritis. A meniscal tear commonly causes knee pain, stiffness, loss of function and sometimes catching or locking of the knee, affecting patients' ability to participate in their everyday activities. In case of ineffective conservative management, meniscal tears are treated with meniscectomy (partial or total) or meniscal repair, with the latter considered, when possible, the optimal choice.

Meniscal repair consists of a suture that juxtaposes the flaps of the injured meniscus to facilitate the healing of the tear. Unfortunately, meniscal healing capability is limited. A higher rate of meniscal tears healing has been documented in patients treated simultaneously with a meniscal repair and anterior cruciate ligament reconstruction. A surgical augmentation technique performing micro-fractures on the medial aspect of the lateral femoral condyle during meniscal repair surgery has been developed to mimic the beneficial effect of anterior cruciate ligament reconstruction on the joint environment. This technique has been successfully tested in preclinical studies, in human cohort studies and, recently, in a randomized control trial. However, these randomised controlled trials present some methodological weaknesses, such as a low number of included patients, and included only full-thickness vertical longitudinal tears in the red-red zone, the meniscal tears with the highest healing potential. The effect of additional micro-fractures on the healing capacity of meniscal tears involving the red-white zone has never been tested.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Arthroscopic confirmed suturable meniscal tears,
  • Monolateral meniscal tears,
  • 18-45 years,
  • BMI>18,5 and <35 kg/m2,
  • Ability to give informed consent by signature.

排除标准

  • Bilateral meniscal tears requiring treatment,
  • Associated ligament lesions requiring treatment,
  • Associated cartilage lesions (Outerbridge > 2),
  • Knee axis deformities requiring correction
  • Generalized ligamentous laxity,
  • Radiographic knee ostheoarthritis,
  • Other reasons for knee pain,
  • Pregnant or lactating women,
  • Serious systemic diseases such as cardiac, hepatic or renal failure, rheumatic diseases, non-compensated diabetic, psychological illnesses, central or peripheral neurological diseases, and autoimmune diseases,
  • Enrolled in another ongoing clinical trial.

研究组 & 干预措施

Control arm

Active Comparator

Meniscal suture alone, without marrow venting procedure

干预措施: Meniscal repair (Procedure)

Marrow venting arm

Experimental

Meniscal suture associated with marrow venting procedure

干预措施: Meniscal repair (Procedure)

Marrow venting arm

Experimental

Meniscal suture associated with marrow venting procedure

干预措施: Marrow venting procedure (Procedure)

结局指标

主要结局

subjective International Knee Documentation Committee (IKDC) score

时间窗: 2 years

evaluated subjective IKDC score 2-years after intervention in two groups

次要结局

  • Pain curves during the first 6 weeks.(6 weeks)
  • Tegner score((prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))
  • Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)((pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))
  • Treatment related adverse events(5 years)
  • Knee Injury and Osteoarthritis Outcome Score - KOOS((pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))
  • Function 0-10 Numerical Rating Scale (NRS)((pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))
  • Healing rate(1 year)
  • Function curves during the first 6 weeks.(6 weeks)
  • Radiographic progression of knee osteoarthritis(5 years)
  • Objective International Knee Documentation Committee (IKDC)((pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))
  • Pain 0-10 Numerical Rating Scale (NRS)((pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years))

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christian Candrian

Principal Investigator

Ente Ospedaliero Cantonale, Bellinzona

研究点 (3)

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