Arthritis Trial Finder

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)

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 21 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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): 1.
anterior-posterior view (weight bearing extension or semi-flexion) of tibiofemoral joint, (posterior-anterior/Rosenberg view as an additional alternate) 2. lateral view of both the tibiofemoral and patellofemoral joints 3. 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

    Exclusion Criteria:

    - 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.
  • - Chronic use of analgesia for pain (including pain in the other knee or any other joint) that may interfere with the evaluations of the test knee (such as possible use of rescue medication for these other conditions).
  • - Known allergies to acetaminophen and hyaluronan preparations.
  • - Know hypersensitivity (allergy) to anesthetics - Recurrent medical history of severe allergic or immune-mediated reactions.
  • - Active infection or skin diseases in the area of the potential injection site or joint.
  • - Any dermatological disease overlying the signal joint that would contraindicate multiple injections or aspirations.
  • - Use of any agent reported to have symptom relief for arthritis or be a disease/structure modifying drug (e.g. doxycycline, long-term tetracycline, s-adenosylmethionine [SAM], methylsulfonylmethane [MSM] or dimethylsulfoxide [DMSO], dietary supplements or any herbal remedy taken for arthritic and joint conditions within the past month (exceptions as specified in Exclusion #14).
  • - Peripheral neuropathy that would be severe enough to interfere with the evaluation of the subject.
  • - Psychological status (e.g., anxiety, depression, poor sleep quality, pain catastrophizing, etc.) that may interfere with functional assessment of the target knee.
  • - Vascular insufficiency of lower limbs that is severe enough to interfere with the evaluation of the subject.
  • - Concomitant therapy with anticoagulants (low dose aspirin, not exceeding 325 mg per day as an anti-thrombotic agent is permitted if stable for 1 month prior to Screening and remains stable throughout the study).
  • - Any concomitant disease(s) or condition(s) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the trial (cancer, other rheumatic diseases, gout, severe congenital defects, etc.).
  • - Any serious mobility problems (e.g. Parkinson's disease) or claustrophobia - Any concomitant chronic disease(s) or condition(s) that may predispose them to a high probability of interfering with the completion of the 6-month follow-up of the study such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer, pregnancy, alcoholism, drug abuse, mental state, or other clinically significant condition.
  • - Excessive alcohol consumption or alcoholism that would be contraindicated with the use of acetaminophen.
  • - Use of marijuana, whether prescribed or not - Any clinically significant diagnostic test and/or abnormal laboratory test result(s) that, in the opinion of the clinical investigator, may place the subject's health at risk, impact the study, or impact the subject's ability to complete the study.
  • - Inability to legally comprehend the details and nature of the study for any reason, including psychiatric illness.
  • - Likelihood of protocol violations or unlikely to compete the study for any reason, as determined by the clinical investigator.
  • - Continued participation in an experimental drug/device study or any clinical trial within the previous 8 weeks prior to Screening.
Subjects must have fully completed participation in an experimental drug/device study of any clinical trial at least 8 weeks prior to screening.
  • - Pregnancy, breastfeeding, planned conception, premenopausal women who have not had tubal ligation, hysterectomy, or are unwilling or unable to utilize contraceptive measures (or contraception) - Prior history of any malignancy with the exception of basal cell carcinoma of the skin treated more than 2 years prior to Screening.
  • - Significant bleeding diathesis.
  • - Participation in current litigation for injuries related to the study knee or other injuries that might interfere with their completion of the study protocol.
  • - Non-English speaking subjects.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03281837

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Fidia Pharma USA Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Cedars-Sinai Medical CenterKerlan-Jobe Orthopaedic Clinic
Principal Investigator Affiliation Cedars-Sinai Medical Center - Department of Orthopaedic SurgeryKerlan-Jobe Orthopaedic Clinic

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Osteoarthritis, Knee, Knee Osteoarthritis, Patellofemoral Osteoarthritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Recruiting

Address

Tucson Orthopaedic Institute Research Center

Tucson, Arizona, 85712

Site Contact

Caroline Holcomb

Cholcomb@tucsonortho.com

520-784-6481

CORE Orthopaedic Medical Center, Encinitas, California

Status

Recruiting

Address

CORE Orthopaedic Medical Center

Encinitas, California, 92024

Site Contact

Farouk Awad

Fawad@coreorthopaedic.com

760-943-6700 #162

Kerlan-Jobe Orthopaedic Clinic, Los Angeles, California

Status

Recruiting

Address

Kerlan-Jobe Orthopaedic Clinic

Los Angeles, California, 90045

Site Contact

Karen Mohr

Karen.Mohr@kerlanjobe.com

310-665-7129

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Denice Dubuclet

denice.dubuclet@cshs.org

310-423-6996

San Diego, California

Status

Recruiting

Address

Horizon Clinical Research / Grossmont Orthopaedic Medical Group

San Diego, California, 91942

Site Contact

Karen Mylerberg

karen@horizontrials.com

619-456-6012

Gulf Breeze, Florida

Status

Recruiting

Address

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

Gulf Breeze, Florida, 32561

Site Contact

Lauren Inman

lauren.inman@andrewsref.org

850-916-8570

Greenwood, Indiana

Status

Recruiting

Address

Cartilage Research Foundation, Inc. - OrthoIndy

Greenwood, Indiana, 46143

Site Contact

Vicki Snodgrass Miller

vsmiller@orthoindy.com

317-884-5230

New York, New York

Status

Recruiting

Address

New York University - Center for Musculoskeletal Care

New York, New York, 10016

Site Contact

Ariel Aponte, CCRC

ariel.aponte@nyumc.org

212-460-0176

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Danielle DiGirolamo

digirolamod@HSS.EDU

212-774-2673

IntegraTrials LLC / OrthoVirginia, Arlington, Virginia

Status

Recruiting

Address

IntegraTrials LLC / OrthoVirginia

Arlington, Virginia, 22205

Site Contact

Deborah Tominack, RN, CCRC

trialsva@erols.com

703-528-0385

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