The MONOVISC Hip Osteoarthritis Study
Condition: Osteoarthritis of the Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: MONOVISC; Saline
Intervention description: Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy); Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This study is being done to determine the effectiveness of MONOVISC for the relief of pain
      and symptoms of osteoarthritis of the hip. Specifically, the study will determine if MONOVISC
      is more effective than a placebo treatment when delivered as intra-articular injections
      (injected directly into the hip joint). In this case, the placebo will be a dilute solution
      of salt water (saline).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 30 years old

          -  Body Mass Index (BMI) ≤ 35

          -  Clinical or radiographic diagnosis of hip osteoarthritis in the target hip, with a
             Kellgren-Lawrence (K/L) grade of 2 or 3.

          -  Walking pain NRS ≥ 4 and ≤ 8.

          -  Willing to discontinue all pain medications (except rescue medication) for 7 days
             prior to the first study injection and for the duration of the study.

          -  Willing to discontinue rescue medication for 48 hours prior to the first study
             injection.

          -  Willing to discontinue rescue medication for 48 hours prior to all follow-up visits

          -  Ability to tolerate acetaminophen (e.g. Tylenol).

          -  Must be physically and mentally willing and able to comply with pre and post-treatment
             scheduled clinical and radiographic evaluations

          -  Must voluntarily sign the Institutional Review Board approved Informed Consent Form.

          -  Must agree not to initiate cannabis therapy during the trial study period.

        Exclusion Criteria:

          -  Radiographic evidence of osteonecrosis in the target hip

          -  NRS walking pain ≥ 3 the contralateral hip

          -  Clinically diagnosed osteoarthritis in either knee resulting in walking pain greater
             than NRS 5.

          -  Dependence on external stabilization for walking (e.g. cane, crutches, walker, etc.)

          -  Pain associated with lower back disorders that cannot be differentiated from target
             hip pain

          -  Major dysplasia or congenital abnormality

          -  Diagnosis of fibromyalgia

          -  Primary inflammatory arthropathy, or any other condition affecting the joint,
             including rheumatoid arthritis or gout in the target hip

          -  Any musculoskeletal condition that could impede efficacy measurement of the target hip

          -  Any major surgery, arthroplasty, or arthroscopy of the lower extremities in the past 6
             months, or planned surgery during the study

          -  Infection of the injection site area

          -  Chronic skin disorders that could interfere with injection site evaluation

          -  Patients with asthma who require systemic use of corticosteroids

          -  Septic arthritis in any joint in the past 12 weeks

          -  For all patients: known hypersensitivity to hyaluronan, lidocaine, or acetaminophen

          -  For patients undergoing fluoroscopic injection guidance: known hypersensitivity to
             iodine-based fluoroscopic contrast agents, shellfish, or iodine

          -  Intra-articular steroid injection of the target hip within the last 3 months or
             hyaluronan injection of the target hip within the last 26 weeks

          -  Systemic corticosteroids within the last 12 weeks

          -  Glucosamine and/or chondroitin sulfate within last 4 weeks

          -  Currently on anticoagulation therapy, including aspirin therapy of > 81 mg/day (e.g.
             one daily "baby aspirin").

          -  Uncontrolled diabetes mellitus.

          -  Pregnant or breast feeding, or plan to be pregnant during the course of the study

          -  Any significant illness (metastasis of any type) that decreases the probability of the
             subject's survival to the 26 week endpoint

          -  Patients unwilling/unable to complete a pain/function and quality of life
             questionnaires

          -  Significant trauma to the index hip within 26 weeks of screening

          -  Is receiving workman's compensation, or is currently involved in litigation relating
             to hip osteoarthritis

          -  Is receiving prescription pain medication for conditions unrelated to hip
             osteoarthritis

          -  Chronic use of narcotics

          -  Unwilling to return for follow-up visits as described in this protocol

          -  Otherwise determined by the investigator to be medically unsuitable for participation
             in this study