Prospective, Randomized, Double Blind Evaluation of the Efficacy of a Single Dose of Synvisc-One® (6.0 cc) for the Treatment of Patellofemoral Chondromalacia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Knee Pain During a Single Leg Squat
研究概览
简要总结
The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in patients with a condition called chondromalacia patella and how well in works in treating the condition.
Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called "Runner's Knee," this condition often affects young, otherwise healthy individuals.
Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally glides effortlessly across the knee during bending of the joint. In some individuals, the cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain. Potential treatments for this condition include rest, injections (numbing or anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening exercises which may help reduce pain.
Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One® is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in joint fluid.
Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far, this drug/device has been given to over 10,000 people who have knee pain (due to osteoarthritis) and has been proven safe and effective in patients with moderate to severe pain due to knee joint osteoarthritis.
详细描述
Study Procedures:
Screening visit:
After written informed consent is obtained, initial screening will consist of a thorough medical history and physical examination and standing, bilateral PA, lateral and merchant view x-ray evaluation. Special attention will be given to inclusion and exclusion criteria as listed above. Only patients who meet all inclusion and exclusion criteria will be allowed to continue to Baseline outcomes data collection and randomization. The following subjective outcomes, clinical examination and quadriceps strength data will be collected at each session.
Subjective Outcomes
- Knee Injury Outcome and Osteoarthritis Score (KOOS)
- Anterior knee pain rating during single-leg squat (10cm visual analog scale-VAS)
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at time of randomization: 18-45 years
- •Clinical diagnosis of anterior knee pain
- •X-ray showing no fracture or osteoarthritis
- •>4 out of 10 on a visual analog scale and/or Knee & Osteoarthritis Outcome Score (KOOS) <7
- •Persistent anterior knee pain lasting at least 3 months prior to screening
- •Failed previous physical therapy intervention
- •Pain/crepitus with patellar grind
排除标准
- •Presence of knee/ patellofemoral joint effusion
- •Patellar tendonitis
- •Patellofemoral joint space narrowing as noted on Merchant/sunrise x-ray
- •Diagnosis of tibiofemoral osteoarthritis
- •Cruciate/ collateral knee ligament instability
- •Patellofemoral joint instability
- •Significant patellar or tibiofemoral mal-alignment
- •Suspected meniscus injury
- •Any clinical indication for arthroscopic surgery
- •Significant patellar mal-tracking as noted on merchant view x-ray
- •Currently enrolled in another experimental clinical trial
- •Patellofemoral joint injection within the past 3 months
- •Known or suspected psychological disorder
- •Known allergy to avian products
- •Oral steroid medications
- •Intra-articular (knee joint) steroids in the past 6 months
- •Any prior use of viscosupplements
- •Pregnant or breast feeding
- •Body mass index > 40
- •Prior surgery in the knees (excludes debridement only procedures)
- •Clinical evidence of hip disease
- •Any form of inflammatory arthritis ( e.g. RA, gout, pseudogout, lupus, etc)
- •Significant co-morbid conditions as determined by the investigator
- •Willing to refrain from chiropractic treatment or acupuncture during the study
- •Any other intra-articular knee joint injection during the study
- •Kellgren Lawrence grade osteoarthritis of II, III or IV
结局指标
主要结局
Knee Pain During a Single Leg Squat
时间窗: Baseline, 1 month, 3 month and 6 month
Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat. The scale ranges from 0-10 where higher numbers indicate more pain. A score of 0 indicates no pain and a score of 10 indicates worst possible pain.
次要结局
- KOOS: Patient Reported Knee Function(Baseline, 1 month, 3 month and 6 month)
- Quadriceps Muscle Function(Baseline, 1 month, 3 month and 6 month)
研究者
Joseph Hart
Principal Investigator
University of Virginia