Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondro… (NCT01771952) | Clinical Trial Compass
CompletedNot Applicable
Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
United States86 participantsStarted 2010-03
Plain-language summary
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.
Who can participate
Age range
15 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 de…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.