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临床试验/NCT05086068
NCT05086068进行中(未招募)不适用

Mechanistic and Clinical Study of Intra-articular Arthrosamid for Knee Osteoarthritis

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score between baseline (pre-injection) and 6 months and 12 months post-injection.

研究概览

简要总结

Prior to surgical intervention, the conservative treatment of knee osteoarthritis involves analgesia and intra-articular injections and currently only steroid injections are available as part of NHS treatment. They have short-term benefit only (<6months) and potentially have detrimental effects on residual cartilage. Arthrosamid is a hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide. It's been shown to be safe and effective, with benefits lasting beyond 2 years in the majority. However, currently it is unclear via what biological pathways it reduces joint inflammation and pain.

This study will investigate the effects of Arthrosamid clinically and biologically.

详细描述

Prior to surgical intervention, the conservative treatment of knee osteoarthritis involves analgesia and intra-articular injections. Currently only steroid injections are available as part of NHS treatment. It is recognised they have short-term benefit only (<6months) and potentially have detrimental effects on residual cartilage. Arthrosamid is a hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide. It's been shown to be safe and effective, with benefits lasting beyond 2 years in the majority. However, currently it is unclear via what biological pathways it reduces joint inflammation and pain.

Patients with osteoarthritis who are offered an intra-articular knee injection as part of standard care will be asked to enter the trial. On entering the trial baseline outcome measures will be recorded. The level of knee pain will be evaluated using Visual Analogue Scale (VAS). Patients will also be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) score and Western Ontario and McMaster Universities Arthritis Index (WOMAC). Patients will also declare the quantity of anti-inflammatory drugs and Oral analgesia that they have consumed.

At the time of treatment, a blood sample will be taken and under sterile conditions, synovial fluid will be aspirated from the knee prior to 6mls of Arthrosamid being injected. Patients will be reviewed by a researcher in a dedicated research clinic at 3,6 and 12 months post injection and the outcome measures repeated. At 3 months post injection synovial fluid and blood will again be collected from the patients. The blood and synovial fluid pre and post injection in patients who respond well to the injection will be compared to the samples from patients who fail to respond. The differences between the biochemical environments will allow us to identify likely pathways by which the injection reduces pain and inflammation.

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

入选标准

  • Primary OA according to the American College of Rheumatology criteria
  • Self-reported pain, aching, or stiffness of the index knee on most days of the past month, and a knee pain score of greater than 40 out of 100 on a visual analogue scale (VAS).
  • Radiological OA greater than Kellgren-Lawrence (K-L) grading scale 2
  • Patients aged over 18 years
  • Patient willing to undergo synovial sampling at 3 months post injection.

排除标准

  • Previous trauma with significant alteration in bone architecture
  • Symptoms of spinal disease
  • Prior injection in the last 12 months
  • Joint re-placement operation on the other knee
  • Cognitive disorders
  • Inflammatory arthritis (i.e., rheumatoid arthritis, spondylarthritis and gout)
  • Fibromyalgia
  • Auto-immune disease (i.e., connective tissue disorders)
  • Previous history of septic arthritis.
  • Unwilling or unable to give informed consent

结局指标

主要结局

Changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score between baseline (pre-injection) and 6 months and 12 months post-injection.

时间窗: 6 months and 12 months post injection

The WOMAC score includes 3 subscales related to pain, stiffness and function; the higher is the WOMAC score, the worse is the joint function.

次要结局

  • Blood and synovial fluid biochemical and biomarker levels pre- and post-injection(Pre-injection and at 3 months)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-injection, 3, 6 and 12 months post-injection)
  • Analgesia requirement 1 week prior to Patient Reported Outcome Measurement (PROM) collection(Pre-injection, 3, 6 and 12 months post-injection)

研究者

发起方
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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