Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
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Purpose
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 | Intervention |
|---|---|
|
Chondromalacia Patella Patellofemoral Pain Syndrome |
Device: Synvisc-One™ Other: Sham Treatment |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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|
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 Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Christopher Kuenze, MA, ATC | 434-924-6184 | cmk7sq@virginia.edu |
| Contact: Joseph Hart, PhD, ATC | 434-924-6187 | joehart@virginia.edu |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Principal Investigator: Joseph Hart, PhD, ATC | |
| Sub-Investigator: Christopher Kuenze, MA, ATC | |
| Principal Investigator: David Diduch, MD | |
| Principal Investigator: | Joseph Hart, PhD, ATC | University of Virginia |
| Principal Investigator: | David Diduch, MD | University of Virginia |
More Information
No publications provided
| Responsible Party: | Joseph Hart, Principal Investigator, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01771952 History of Changes |
| Other Study ID Numbers: | 14386 |
| Study First Received: | May 15, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Virginia:
|
Patellofemoral Chondromalacia Anterior Knee Pain Patellofemoral Pain Syndrome Synvisc-One Hyaluronic Acid |
Additional relevant MeSH terms:
|
Cartilage Diseases Chondromalacia Patellae Somatoform Disorders Patellofemoral Pain Syndrome Musculoskeletal Diseases Connective Tissue Diseases Mental Disorders |
Joint Diseases Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013