Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia

Completed · Not applicable · Has a placebo group

Conditions studied: Chondromalacia Patella, Patellofemoral Pain Syndrome

In brief

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.

Key facts

Study ID

NCT01771952

Run by

University of Virginia

People needed

86

Starts

2010-03-01

Expected to finish

2016-10-01

Last updated by the study team

2020-09-04

Who can join

Age: 15 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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