Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip Controlled With Intra-articular Injections With Bupivacaine
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Harris Hip Score
研究概览
简要总结
Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee.
Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%.
Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age between 30 and 70years
- •radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
- •chronic pain for at least 3 months prior to study entry (day 0)
- •dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs.
排除标准
- •Kellgren and Lawrence grade 4
- •an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months
- •non compliance to the study procedures and or non completion of the study according to investigator's judgment
- •rapid destructive hip.
- •a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy
- •a current other problem in the affected extremity
- •contra-indications for the use of corticosteroids (gastrointestinal ulcer, severe osteoporosis, psychiatric anamnesis, herpes simplex or zoster (viremic stadium), varicella, 8 weeks before and 2 weeks after immunization, systemic mycosis, poliomyelitic except of bulbar encephalitic form lymphadenitis after BCG-vaccination, parenteral depot medication, closed- and wide-angle glaucoma)
- •allergy or hypersensitivity to any of the study medications or to contrast solutions.
研究组 & 干预措施
HA
Coxarthrosis
干预措施: Corticosterone (Drug)
Corticosterone
Coxarthrosis
干预措施: Corticosterone (Drug)
Bupivacaine
Coxarthrosis
干预措施: Corticosterone (Drug)
结局指标
主要结局
Harris Hip Score
时间窗: 0 - 6 - 12 - 26 weeks
this score will be used as a self-administered questionnaire in accordance with the developers' instructions. The Harris Hip Score was first developed in 1967 and is accepted as one of the best used questionnaires dealing the hip function. It is a disease-specific scoring system which was introduced to provide an evaluation system for various hip disabilities and methods of treatment. This Score gives a maximum of 100 points, with domains of pain, function, deformity and motion.
次要结局
- Visual Analog Score(0 - 6 - 12 - 26 weeks)