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NCT01771952 · ClinicalTrials.gov registry record · NA
Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 86
- Enrollment target
NCT01771952 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 86 participants.
The verdict
NCT01771952, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
Study 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.
Interventions
- OTHER Sham Treatment
- DEVICE Synvisc-One™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2010-03 |
| Est. Completion | 2016-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01771952
The ClinicalTrials.gov registry entry for NCT01771952 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham Treatment is the first listed.
NCT01771952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01771952 about?
NCT01771952 is a clinical study titled "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 ...
What is the current status of trial NCT01771952?
This trial is currently completed. It is a NA study. The enrollment target is 86 participants. The study started on 2010-03. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01771952?
The interventions under investigation include: Sham Treatment (OTHER), Synvisc-One™ (DEVICE).
Who is sponsoring clinical trial NCT01771952?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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