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)

NCT03281837 | Completed FDA Device

• 1 other identifier: EQE7-16-01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Knee Osteoarthritis; Patellofemoral Osteoarthritis

Keywords

osteoarthritis; knee osteoarthritis; patellofemoral osteoarthritis; tibiofemoral osteoarthritis; hyaluronan; hyaluronic acid; intra-articular; arthritis; joint disease; active; viscosupplements; Hymovis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 90 days after baseline

Secondary Outcomes (7)

• Safety - Number of participants with intervention / treatment-related adverse events

  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

  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

  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

  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

  Baseline, 90 days, 180 days, through study completion (1 year)

Study Arms (3)

Group 1: Hymovis plus Physical Exercise Program (PEP)

EXPERIMENTAL

Intra-articular (IA) Hyaluronan (HA) (Hymovis 24mg/3mL) combined with Physical Exercise program (PEP)

Device: HYMOVIS plus Physical Exercise Program (PEP)

Group 2: Physical Exercise Program (PEP) alone alone

OTHER

Specified designed Physical Exercise Program (PEP) not combined with any other intervention

Other: Physical Exercise Program (PEP) alone

Group 3: Cross-Over group

OTHER

Patients who were randomized to receive only Physical Exercise Program (PEP) alone and do not respond after 3 months to this intervention will have the opportunity to cross-over to receive 2 intra-articular weekly injections, each injection given 1 week apart, of Hymovis.

Device: HYMOVIS plus Physical Exercise Program (PEP)

Interventions

HYMOVIS plus Physical Exercise Program (PEP) DEVICE

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)

Group 1: Hymovis plus Physical Exercise Program (PEP); Group 3: Cross-Over group

Physical Exercise Program (PEP) alone OTHER

Physical Exercise Program (PEP) alone for at least 8 weeks

Group 2: Physical Exercise Program (PEP) alone alone

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Fidia Pharma USA Inc.: lead

Study Sites (10)

Tucson Orthopaedic Institute Research Center

Tucson, Arizona, 85712, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Kerlan-Jobe Orthopaedic Clinic

Los Angeles, California, 90045, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Horizon Clinical Research / Grossmont Orthopaedic Medical Group

San Diego, California, 91942, United States

Location

Andrews Institute Orthopaedics and Sports Medicine - Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Cartilage Research Foundation, Inc. - OrthoIndy

Greenwood, Indiana, 46143, United States

Location

New York University - Center for Musculoskeletal Care

New York, New York, 10016, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

IntegraTrials LLC / OrthoVirginia

Arlington, Virginia, 22205, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Joint Diseases; Motor Activity

Interventions

Single Person

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Cedars-Sinai Medical Center

  Cedars-Sinai Medical Center - Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Kerlan-Jobe Orthopaedic Clinic

  Kerlan-Jobe Orthopaedic Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. There will be a blinded evaluator who will not be informed about the intervention (Hymovis + PEP or PEP alone) to which study subjects will be randomized
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 HYMOVIS injections combined with a physical exercise program (PEP) to 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 a 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 Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: October 1, 2017
• Primary Completion: July 9, 2020
• Study Completion: July 16, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

US (10)