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临床试验/NCT04641351
NCT04641351进行中(未招募)4 期

Injection After Arthroscopic Partial Meniscectomy

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
150
试验地点
2
主要终点
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.

研究概览

简要总结

Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population.

Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.

详细描述

Symptomatic meniscal tear with pain and mechanical symptoms of catching and locking ,a phenotype of early OA, and often prompts patients who have failed physical therapy to elect APM to improve their symptoms. This arthroscopic surgery presents a unique opportunity to evaluate the intraarticular status of the joint including joint fluid biomarkers and synovial tissue for signs of inflammation in patients with mild to moderate OA. Since no post-op tissue repair is desired after APM, in contrast to other post-traumatic OA (PTOA) models such as anterior cruciate ligament reconstruction, the APM cohort can be used to test novel interventions to slow down PTOA development by suppressing synovitis and inflammation. Results from this trial in this patient population could be applied to the broader population of many millions of patients with mild to moderate OA who never undergo arthroscopy.

There are currently approximately 1,000,000 APMs performed in the United States each year, and about 70 percent of patients have a clinically significant improvement in symptoms after surgery. Much of this variation in outcome is unexplained but is hypothesized to be related to synovitis and joint inflammation that is currently unmeasured and untreated in usual clinical care.

This is a randomized controlled trial of extended release triamcinolone for efficacy to improve patient reported outcome measures after APM. The investigators will evaluate joint fluid and synovial tissue biomarkers to assess joint inflammation as a predictor of treatment response, use quantitative 3T MRI to evaluate cartilage and meniscus composition and 3D bone shape, which are sensitive imaging markers for early joint degeneration, and use a prospective surgical episode data collection system to capture patient reported outcomes and surgeon reported operative data.

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 (Care Provider, Investigator)

入排标准

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

入选标准

  • Male or female age 40 and older
  • Scheduled for APM with enrolling surgeon
  • Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

排除标准

  • Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide
  • Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting)
  • Injection with corticosteroid into affected knee in past 12 weeks
  • Injection with platelet rich plasma into affected knee in past 12 weeks
  • Injection with hyaluronic acid into affected knee in past 24 weeks
  • Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure
  • Bilateral surgery
  • Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc.
  • Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)

研究组 & 干预措施

corticosteroid

Experimental

Triamcinolone extended release (32 mg) administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy.

  • Knee injury and Osteoarthritis Outcome Score (KOOS) pain at 6 and 12 months
  • T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months
  • Morphologic grading of cartilage using the MOAKS score at 3 and 12 months
  • 3D bone shape from MRI Osteoarthritis Knee Score (MOAKS) using statistical shape modeling at 3 and 12 months
  • Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months

干预措施: Zilretta Injectable Product or Placebo (Drug)

Placebo

Placebo Comparator

Normal saline of 5 mL administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy.

  • KOOS pain at 6 and 12 months
  • T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months
  • Morphologic grading of cartilage using the MOAKS score at 3 and 12 months
  • 3D bone shape from MRI using statistical shape modeling at 3 and 12 months
  • Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months

干预措施: Zilretta Injectable Product or Placebo (Drug)

结局指标

主要结局

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.

时间窗: 0 and 3 months

Knee pain of participants; a higher score represents a desired outcome; zero representing extreme knee problems and 100 representing no knee problems

次要结局

  • Change in Magnetic Resonance Imaging relaxation time (milliseconds of T1 and T2) from baseline, 3, and 12 months.(0, 3 and 12 months)
  • Change in Whole-Organ Magnetic Resonance Imaging Score (WORMS) from baseline, 3, and 12 months.(0, 3 and 12 months)
  • Change in Magnetic Resonance Imaging morphological grading from baseline, 3, and 12 months.(0, 3 and 12 months)
  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline, 6 and 12 months.(0, 6, and 12 months)
  • Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.(0, 3 and 12 months)
  • Change in Inflammatory biomarkers of the knee joint from baseline, 3, and 12 months.(0, 3, and 12 months)
  • Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.(0, 3, and 12 months)

研究者

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

Kurt Spindler, MD

Grant PI

Arthritis Foundation

研究点 (2)

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