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The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.
Full description
This is a multi-center, randomized, double-blind, active comparator-controlled, non-inferiority study to assess the efficacy and safety of a single injection of Hymovis ONE® for the relief of pain in subjects with OA of the knee by establishing its non-inferiority to Monovisc™.
The entire study will last approximately 19 months. Patients will participate in the study for approximately 28 weeks (from screening to the last visit).
The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE® to a single injection of Monovisc™. Both products are high molecular weight HA preparations, specifically sodium hyaluronate from bacterial fermentation, supplied sterile as a single dose of 4 ml in a 5 ml syringe.
Subjects will undergo an evaluation consisting of a thorough discussion of medical history, demographics, followed by a physical examination and vital signs (blood pressure and heart rate) measurement.
The evaluation of their activity level through the Tegner activity level scale, a graduated list of ADLs, recreation, and competitive sports will be performed. The patient is asked to select the level of participation that best describes their current level of activity through an Investigator's interview. The Tegner activity level scale is filled in by Investigator.
In this study, one single IA injection of Hymovis ONE® or Monovisc™ will be performed at the investigational site, under the tight supervision of an experienced treating specialist. Therefore, there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol. Furthermore, the use of only one IA injection should further contribute to limit the risk of adverse effects. Therefore, it is expected that benefits from participation in this study will outweigh the potential risks.
Enrollment
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Inclusion criteria
Female and male subjects ≥ 40 and ≤ 75 years of age
Body mass index (BMI) ≥20 and <35 kg/m2
Tegner score ≥3
Subjects with primary knee OA of the medial or lateral femorotibial compartment with symptoms at screening and for at least 3 months prior to screening according to American College of Rheumatology (ACR) criteria and who have not responded to conservative non-pharmacologic treatment or simple analgesic regimens
Subjects with Kellgren-Lawrence (K-L) radiological grade 2 or 3 in the target knee
Subjects with at least one X-Ray image of the target knee taken at screening or within 6 months prior to the screening.
Subjects with OA pain intensity meeting the criteria below:
Willingness to discontinue oral and topical analgesics including NSAIDs and accept "rescue" paracetamol as the only medicine for joint pain prior to the injection and throughout the study. "Rescue" medication will be discontinued 24 hours before any study visit
Subjects able to understand and willing and able to comply with study procedures
Subjects able to provide informed consent
If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable form of contraception throughout the study*.
Note: To be considered of non-childbearing potential, females must be surgically sterile or postmenopausal for at least 1 year.
*Highly effective birth control methods include: combined hormonal contraception containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine ormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Exclusion criteria
Inability to perform a 50-foot walk test
Subjects with secondary (post-traumatic) knee OA of the target joint
Subjects with K-L radiological grade 1 or 4 in the target knee
Subjects with known X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and /or severe bone or joint deformity in the target knee
Clinically apparent tense effusion of the target knee on examination (determined by either a positive bulge sign or ballottement of the patella (patellar tap))
Subjects with osteonecrosis of either knee
Subjects with a history of knee joint replacement or arthroplasty of the target knee
Subjects with a history of arthroscopy of the target knee in the past 6 months
Subjects with a history of osteotomy or surgery of the target or contralateral knee and any other weight-bearing joint that would have interfered with knee assessment
Subjects with acute, recurrent synovitis, or any inflammatory conditions in the target knee
Subjects with any significant injury to the target knee in the last 6 months (as per Investigator judgment)
Subjects with any musculoskeletal condition affecting the target knee that would impair the proper assessment of the
Investigational Medical Device (IMD) performance in the target knee as assessed by the Investigator such as:
Subjects with health condition associated with pain which may interfere with study variables evaluation
Subjects with a known history or present evidence of conditions which may affect the target knee assessments, like rheumatic disease, lupus arthropathy, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteoarticular pathologies differing from arthrosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
Subjects with gout or calcium pyrophosphate (pseudogout) diseases of the target knee with flare-ups within 6 months prior to screening
Subjects with fibromyalgia, pes anserine bursitis, lumbar radiculopathy and/or neurogenic or vascular claudication
Subject with significant anterior knee pain due to the diagnosed isolated patellar-femoral syndrome or chondromalacia in the target knee
Subjects with symptomatic OA of the hips, spine or ankle that interferes with the evaluation of the target knee
Subjects with venous or lymphatic stasis in the relevant limb
Subjects with a history of the following treatments:
Subjects with a history of chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
Subjects treated with agents which alter the perception of pain such as hypnotics, muscle relaxants, anxiolytics if the intake has started less than 8 days before screening
Subjects with a history of recurrent severe allergic or immune-mediated reactions or other immune disorders
Subjects with vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere
Subjects with active liver disease
Subjects with any clinically significant laboratory values which, based on investigator judgment and subject clinical history, may affect study evaluation
Subjects who currently use heparin or anti-vitamin K (e. g. crystalline warfarin) anticoagulant therapy
Subjects with infections, wounds, bruising, disease or trauma in the area of the injection site or joint
Subjects with suspected or known history of hypersensitivity to paracetamol, lidocaine, hyaluronic acid or to hyaluronate preparations or gram-positive bacterial proteins
Subjects with any surgical procedures scheduled in the next 6 months
Subjects who have participated in a clinical study or investigation in the last 3 months
Pregnant or lactating women, and women of childbearing potential unwilling to use adequate contraception and conduct a pregnancy test at screening.
Primary purpose
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Interventional model
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350 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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