Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
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.
Patellofemoral Pain Syndrome
Other: Sham Treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Double Blind Evaluation of the Efficacy of a Single Dose of Synvisc-One® (6.0 cc) for the Treatment of Patellofemoral Chondromalacia|
- Knee pain during a single leg squat [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat.
- Patient reported knee function [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]Patients will be asked to complete several validated questionnaires to assess their knee symptoms and daily function.
- Quadriceps muscle function [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]Participants will contract their thigh muscle as hard as possible in order to measure their maximum strength. Participants will repeat this test however, an electrical stimulus will be delivered directly to the muscles at the front of your thigh when maximum strength is achieved. This stimulus will cause your thigh muscle to twitch quickly.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.
A single 6cc injection of Synvisc-One™ will be utilized in this study.
Sham Comparator: Sham Treatment
Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.
Other: Sham Treatment
A single needle stick without arthrocentesis or injection.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771952
|Contact: Joseph Hart, PhD, ATCfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator: Joseph Hart, PhD, ATC|
|Sub-Investigator: David Diduch, MD|
|Principal Investigator:||Joseph Hart, PhD, ATC||University of Virginia|
|Principal Investigator:||David Diduch, MD||University of Virginia|