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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01771952
Recruitment Status : Unknown
Verified December 2014 by Joseph Hart, University of Virginia.
Recruitment status was:  Recruiting
First Posted : January 18, 2013
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):
Joseph Hart, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Chondromalacia Patella Patellofemoral Pain Syndrome Device: Synvisc-One™ Other: Sham Treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Synvisc-One™
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.
Device: Synvisc-One™
A single 6cc injection of Synvisc-One™ will be utilized in this study.
Other Names:
  • Hyaluronan
  • Hyaluronic Acid

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.

Primary Outcome Measures :
  1. Knee pain during a single leg squat [ Time Frame: 6 months after treatment ]
    Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat.

Secondary Outcome Measures :
  1. Patient reported knee function [ Time Frame: 6 months after treatment ]
    Patients will be asked to complete several validated questionnaires to assess their knee symptoms and daily function.

  2. Quadriceps muscle function [ Time Frame: 6 months after treatment ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01771952

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Contact: Joseph Hart, PhD, ATC 434-924-6187

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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Principal Investigator: Joseph Hart, PhD, ATC         
Sub-Investigator: David Diduch, MD         
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Joseph Hart, PhD, ATC University of Virginia
Principal Investigator: David Diduch, MD University of Virginia

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joseph Hart, Principal Investigator, University of Virginia Identifier: NCT01771952     History of Changes
Other Study ID Numbers: 14386
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Joseph Hart, University of Virginia:
Patellofemoral Chondromalacia
Anterior Knee Pain
Patellofemoral Pain Syndrome
Hyaluronic Acid
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Cartilage Diseases
Chondromalacia Patellae
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents