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

Study Procedures:

Screening visit:

After written informed consent is obtained, initial screening will consist of a thorough medical history and physical examination and standing, bilateral PA, lateral and merchant view x-ray evaluation. Special attention will be given to inclusion and exclusion criteria as listed above. Only patients who meet all inclusion and exclusion criteria will be allowed to continue to Baseline outcomes data collection and randomization. The following subjective outcomes, clinical examination and quadriceps strength data will be collected at each session.

Subjective Outcomes

• Knee Injury Outcome and Osteoarthritis Score (KOOS)
• Anterior knee pain rating during single-leg squat (10cm visual analog scale-VAS)

Quadriceps strength testing

• Maximal, normalized isometric knee extension force (N/kg)

Randomization:

Each subject will be randomly assigned in a 1:1 ratio to receive one of the treatments (group) described above. Randomization will be done a priori via a random number generator. Group assignments will be sealed in an envelope each containing a number from 001-100. Randomization envelope #001 will be used for the first subject, #002 for the second and so on.

Blinding:

Both examiner and patient will be blinded to treatment/ group assignment. During the injection procedure, we will block patients' view of the injection with the use of a physical screen (pillowcase, blanket, sheet, etc) in order to assure the patient is blinded to treatment. Patients will be "un-blinded" after the final study endpoints have been collected or if needed due to early withdraw or other medical emergency. To maintain blinding and avoid measurement bias, the injecting physician will be different from the investigators performing outcomes assessments.

Medication/ Treatment Restrictions and Monitoring:

• Patients will be instructed to refrain from any other intra-articular treatment or therapy while enrolled in this study
• Patients will be interviewed regarding medication usage (dosage and frequency) at each visit.
• Patients will be instructed to refrain from using any medicine for pain with the exception of OTC Tylenol.

Standardized Exercise prescription:

Patients will be prescribed a standardized home-based quadriceps strengthening program. Patients will be educated on duration and frequency for exercises and will be provided an exercise log that will provide exercise descriptions and reminders as well as a method for exercise compliance. Subjects will return exercise books at each visit for compliance recording.

Follow-up visits

• 1 month following injection: Patients will return at 4 weeks (approx 30±7 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events
• 3 months following injection: Patients will return at 12 weeks (approx 91±7 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events
• 6 months following injection: Patients will return at 26 weeks (approx 182±14 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events

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