Clinical trial NCT02698865: The MONOVISC Hip Osteoarthritis Study
Official title: A Pivotal Study Comparing Two Injections of MONOVISC to Two Injections of Saline in Patients With Osteoarthritis of the Hip
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis of the Hip
Lead sponsor: DePuy Mitek
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: The primary objective of this study is determine whether two intra-articular injections of MONOVISC, separated by 1 month, are superior to two intra-articular injections of physiologic saline, separated by 1 month, in relieving hip osteoarthritis pain, as determined by reduction in walking pain change from baseline.

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

Primary outcomes:
measure: Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180
timeFrame: Baseline and Day 180
Secondary outcomes:
measure: Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120
timeFrame: Baseline, Day 14, 28, 60 and 120
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopedic Institute
state: Arizona
city: Encinitas
country: United States
facility: CORE Orthopedic Medical Center
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center/Desert Orthopedic Center
state: California
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute
state: California
city: Denver
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Denver
country: United States
facility: Denver Hip and Knee
state: Colorado
city: Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Brookhaven
country: United States
facility: Emory Sports Complex
state: Georgia
city: Des Moines
country: United States
facility: Iowa Orthopedic Center
state: Iowa
city: Peabody
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Ann Arbor
country: United States
facility: MedSport - University of Michigan
state: Michigan
city: Cherry Hill
country: United States
facility: Professional Orthopedics
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Sports Medicine Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Garfield Heights
country: United States
facility: Cleveland Clinic
state: Ohio
city: Media
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Bedford
country: United States
facility: Texas Orthopedic Specialists
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: Inov8 Orthopaedics
state: Texas
city: San Antonio
country: United States
facility: San Antonio Orthopaedic Group
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lansdowne Town Center
country: United States
facility: National Sports Medicine Institute
state: Virginia
city: Lynchburg
country: United States
facility: OrthoVirginia
state: Virginia
Study officials:
affiliation: DePuy Synthes Mitek Sports Medicine
name: Brooks J Story, PhD
role: STUDY_DIRECTOR
References: