2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA)

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee, Knee Osteoarthritis, Patellofemoral Osteoarthritis

In brief

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.

Key facts

Study ID: NCT03281837
Run by: Fidia Pharma USA Inc.
People needed: 148
Starts: 2017-10-01
Expected to finish: 2020-07-16
Last updated by the study team: 2020-07-21

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female ≥21 years and ≤60 years old and with BMI ≤40
Moderate to severe knee OA pain ≥3 and ≤8 on the NRS pain subscale in the affected knee (signal knee)
Mild or no pain ≤3 on the numeric rating scale (NRS) pain subscale in the contralateral knee (unaffected knee)
Persistent knee pain lasting at least 3 months prior to Screening
Active life-style (play or train themselves at least 2 to 3 times per week)
Diagnosis of knee OA confirmed by radiographic assessment (must be performed within 6 months prior to screening visit):
anterior-posterior view (weight bearing extension or semi-flexion) of tibiofemoral joint, (posterior-anterior/Rosenberg view as an additional alternate)
lateral view of both the tibiofemoral and patellofemoral joints
Merchant X-ray (or Sunrise) view for patellofemoral joint.
Radiographic assessment must confirm K-L Grade 1 to 3 for TFOA and/or K-L Grade 1 to for PFOA.
Radiographic assessment confirms normal articulation of patella and trochlea in Merchant (or Sunrise) view

You may not qualify if…

Radiographic assessment confirms abnormal patellofemoral tracking or articulation in lateral and/or Merchant view (or Sunrise View)
Major injury to or disorder of the contralateral knee or other weight-bearing joint that would interfere with the study assessments.
Secondary OA of the study joint due to a prior or concomitant condition (e.g., septic arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia, or congenital abnormality, hemochromatosis, etc.).
Surgery to the study joint within the previous 12 months prior to Screening. Surgery to the contralateral knee or other weight-bearing joint within the previous 12 months that would interfere with the study assessments.
Patients with either total joint replacement implants, unicondylar implants or patellofemoral replacement implants in the affected joint.
Ligament reconstruction of the affected knee within 3 years.
Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis.
Episode of gout or calcium pyrophosphate (pseudogout) diseases within 6 months prior to Screening.
IA or local peri-articular corticosteroid injections to the study joint/knee within 8 weeks (2 months) prior to Screening or to any other joint (other than the study joint) or soft tissue area within 1 month prior to Screening.
Any oral corticosteroid within 1 month prior to Screening. Steroid inhalants are permitted if the Subject has been on a stable regimen for the past 1 month prior to Screening and remains on this regimen throughout the course of the trial.
Intra-articular HA in the study joint within 6 months prior to Screening.
History of allergic reaction to an intra-articular Hyaluronic acid injection.
Known hypersensitivity (allergy) to gram positive bacterial proteins.
Use of glucosamine or chondroitin sulfate containing products unless the subject is on stable doses for at least 14 days prior to Screening and willing to remain on these stable doses throughout the course of the study.
Inability to perform the climbing stair test.
X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity.
Axial deviation of the lower limbs greater than 20 degrees in valgus or varus on standing X-ray.
Symptomatic OA of either hip or spine with a pain score ≥2 on the NRS on or off pain medication.
Clinically significant medio-lateral and/or anterior-posterior instability.
Osteonecrosis of either knee.
Participation in a physical therapy regimen that has not been stable during the 1 month prior to Screening and the subject is unwilling or unable to maintain the same regimen throughout the course of the trial or is unwilling to stop previously prescribed or self-initiated physical therapy regimen and switch solely to and initiate study defined PEP program.
K-L Grade 4 TFOA of the knee (i.e., large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
K-L Grade 4 PFOA of the knee (i.e., large osteophytes, marked narrowing, severe sclerosis, definite deformity)
Hemiparesis of the lower limbs.
Significant surgery of lower limbs (hip, ankle, foot) that may interfere with knee assessments.

Where it is running

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

Full record on ClinicalTrials.gov

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