NCT03125499已完成不适用
A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Evaluate the long-term changes in patellar cartilage thickness
研究概览
简要总结
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
详细描述
No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100
- •Cruciate and collateral ligament stability as assessed by screening history and clinical examination
- •Stable medial and lateral menisci as assessed by screening history and clinical examination
- •Able to read, understand, sign and date the subject informed consent
排除标准
- •Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- •Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
- •History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
- •Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before enrollment
- •Last intra-articular knee injection of corticosteroids < 3 months before enrollment
- •Use of any steroids (except inhaled corticosteroids for allergy or respiratory problems) during the previous month before enrollment
- •History of arthroscopy in either knee in the 3 months before enrollment
- •History of septic arthritis, gout or pseudo-gout in either knee in the 12 months before enrollment
- •Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
- •Active systemic infection
- •Participation in other clinical osteoarthritis drug studies, except for studies TPX-100-1 and TPX-100-2, within two years prior to enrollment in TPX-100-4.
结局指标
主要结局
Evaluate the long-term changes in patellar cartilage thickness
时间窗: Between 24 and 34 months from initial drug treatment
Quantitative analysis of long-term changes in patellar cartilage thickness by MRI
次要结局
- Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI(Between 24 and 34 months from initial drug treatment)
- Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees(Between 24 and 34 months from initial drug treatment)
- Examine intra-subject longitudinal changes in Patient reported outcome measures(Between 24 and 34 months from initial drug treatment)
研究者
研究点 (1)
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