Knee osteoarthritis (OA) is among the most common causes of musculoskeletal pain and disability. At present, there is no cure for OA. Therefore, the primary aims of therapy are to reduce pain, maintain or improve function and mobility, and prevent or slow the progression of adverse changes to the joint tissues, while keeping potential therapeutic toxicities to a minimum. Current treatment guidelines begin with non-pharmacologic modalities, such as patient education, weight loss, and physical therapy. Several exercise-based therapeutic approaches, such as aerobic exercise programs, range-of-motion exercises, and muscle-strengthening exercises are recommended and have shown clinical benefit in randomized, controlled clinical trials. However, non-pharmacologic approaches frequently provide insufficient pain relief and restoration of function and mobility, and pharmacologic modalities become necessary. Although simple analgesics such as acetaminophen provide relief for many OA subjects with mild to moderate pain, alternatives should be considered for subjects who fail to obtain adequate symptomatic relief with these measures. This post-market, single blind, multicenter, randomized, controlled clinical study is designed to enroll a relatively young, active population of subjects with patellofemoral osteoarthritis (PFOA) and/or tibiofemoral osteoarthritis (TFOA), and to compare responses to treatment with 2 weekly intra-articular (IA) hyaluronan (HA) injections, with each injection given 1 week apart, of HYMOVIS combined with a physical exercise program (PEP) to PEP alone. Because PEP or exercise programs may be considered the first line standard of care in OA knee pain, particularly in younger, active patients, the hypothesis of the study is that Hymovis combined with PEP program provides greater relief of pain associated with knee OA in the enrolled study subjects than with use of PEP alone. The study provides for subjects randomized to the PEP alone study group to cross over to HYMOVIS+PEP if improvement has not been achieved by the 3 month follow up visit. Subjects will be recruited over an 18 month period. The duration of the trial per center will be approximately 27 months. This includes the enrollment period of 6 months, the follow-up period at 3 and 6 months and the additional follow-up period for patients who crossed-over; they will be followed for an additional 6 months following the initial 3month follow-up. The trial will end when the last subject makes the last visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
1 injection of intra-articular (IA) hyaluronan (HA), Hymovis 24mg/3ml, injection per week for 2 weeks combined with at least 8 weeks of Physical Exercise Program (PEP)
Physical Exercise Program (PEP) alone for at least 8 weeks
Tucson Orthopaedic Institute Research Center
Tucson, Arizona, United States
CORE Orthopaedic Medical Center
Encinitas, California, United States
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Horizon Clinical Research / Grossmont Orthopaedic Medical Group
San Diego, California, United States
Andrews Institute Orthopaedics and Sports Medicine - Andrews Research & Education Foundation
Gulf Breeze, Florida, United States
Cartilage Research Foundation, Inc. - OrthoIndy
Greenwood, Indiana, United States
New York University - Center for Musculoskeletal Care
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
IntegraTrials LLC / OrthoVirginia
Arlington, Virginia, United States
Improvement in average score for 4 of the 5 Knee Injury and Osteoarthritis Outcome Score subscales (KOOS) over 3 months from baseline (Day 90). Scores to be measured are pain, symptoms, function in sport and recreation, and knee related quality of life.
Time frame: Baseline and 90 days after baseline
Safety - Number of participants with intervention / treatment-related adverse events
The investigator's determination and term of each adverse event (AE) will be mapped to system organ class and preferred term using the MedDRA dictionary. Incidence and frequency of AE's will be summarized for each treatment group by MedDRA system organ class and preferred term. A subject will only be counted once per system organ class and once per preferred term within a treatment. The summaries will include: All adverse events, All adverse events by severity, All adverse events by relationship to the study device, All adverse device effects, All adverse events leading to discontinuation from study
Time frame: Baseline, 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, through study completion (1 year)
Time to onset and duration of pain relief at all post-baseline points for the duration of the study
Time frame: Baseline, 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, through study completion (1 year)
Number of subjects achieving pain-free or disability-free return to sports over the duration of the study
Time frame: Baseline, 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, through study completion (1 year)
Analysis on the need for rescue analgesic medication for pain relief
Time frame: Baseline, 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, through study completion (1 year)
Global assessments and SF-12 conducted by the clinicians and self-reported by the subjects
Time frame: Baseline, 90 days, 180 days, through study completion (1 year)
Number of subjects continuing to cross-over phase of study due to failure to respond adequately to PEP alone
Time frame: Baseline, 90 days, 180 days, through study completion (1 year)
Biochemical serum biomarker analysis.
Time frame: Baseline, 90 days, 180 days, through study completion (1 year)
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