Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
Chondromalacia Patella, Patellofemoral Pain Syndrome
About this trial
This is an interventional treatment trial for Chondromalacia Patella focused on measuring Patellofemoral Chondromalacia, Anterior Knee Pain, Patellofemoral Pain Syndrome, Synvisc-One, Hyaluronic Acid
Eligibility Criteria
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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Synvisc-One™
Sham Treatment
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.
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.