Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT04093232
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2019-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Synovial fluid and peripheral blood samples will be cryopreserved for biomarkers of cartilage health and catabolic or anabolic protein measurements are to be correlated with clinical improvement post Hymovis injection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC scores (Western Ontario and McMaster University Osteoarthritis Index)', 'timeFrame': 'Change from baselinescore values to those over 12 months', 'description': 'Self reported numeric values: on pain, stiffness and 17 items of limitations on physical function scored as 0-5 (none, mild, moderate, severe or extreme)'}, {'measure': 'SF 36 scores (Quality of Life Questionnaire)', 'timeFrame': 'Change from baseline score values to those over 12 months', 'description': "Self reported numeric values based upon multiple domains; assessment of over all health, 0-4, (excellent , very good, good, fair and poor) and score compared to the prior year, 0-4, (much better, somewhat better, about the same, somewhat worse, much worse) and 10 functional daily living activity questions with score 0-2, (not at all limited, limited a little, and limited a lot) and 4 questions on patients health compared to others expectations or worsen or excellent health and if they more easily become sick 0-4, (false, mostly false, don't know, mostly true or definitely true. Higher scores indicate worse health and disability."}, {'measure': 'VAS (Visual analogue scale) score for self reported pain', 'timeFrame': 'Change from baseline score values to those over 12 months', 'description': 'Self Reported patient assessment of pain from 0 I(no pain) on the left to 10 worst pain ever. The paint selects their value on a continuous 10 cm line. A higher numeric number on a 0 -10 scale selected indicates more severe pain.'}, {'measure': '6 minute walking distance', 'timeFrame': 'Change in distance walked from baseline to that distance walked over 12 months', 'description': 'The measured distance in meters walked during a 6 minute supervised walk on level ground.'}, {'measure': 'Synovial fluid depth', 'timeFrame': 'Change in the depth of knee synovial fluid from baseline values to those at 12 months', 'description': 'Ultrasound measurement in millimeters of the maximum SF depth during external pneumatic compression.'}], 'secondaryOutcomes': [{'measure': 'Synovial fluid and peripheral blood biomarkers', 'timeFrame': 'Change in the baseline levels of biomarkers in pg/ml to the levels 3 months after the first of 2 Hymovis injections', 'description': '54 separate cytokines ,chemokines and proteins which can impact cartilage health will be measured in the synovial fluid by ELISA and Luminex multiplex platforms on cryopreserved samples to determine the levels of these catabolic inflammatory or anabolic proteins which may impact cartilage health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This NJH Investigator Initiated Study funded by Fidia will prospectively perform 2 ultrasound (US) guided knee aspirations in patients with knee osteoarthritis using a pneumatic compressive device (KneeTap ™) at baseline and at 3 months following 2 Hymovis® injections. Synovial fluid catabolic and anabolic proteins will be compared to those values in the peripheral blood and correlated with clinical outcome measurements at 3 ,6 and 12 months compared to baseline values; WOMAC, SF 36, visual analog pain scale, 6 minute walking distance and SF volumes quantitated by US.', 'detailedDescription': '50 Subjects between 21-80 years with a BMI \\< 40 with mild to moderate knee osteoarthritis on x ray (KL grade II or III) will have a ultrasound guided arthrocentesis with an external pneumatic compression device (KneeTap) and if \\> 0.5 ml of synovial fluid is obtained they will received the first of 2 FDA approved Hymovis knee injections. A second ultrasound guided Hymovis intra-synovial space injection will be administered in one week with a repeat arthrocentesis in 3 months. Subjects will be compensated $ 50 for each of 4 of 5 study visits. Clinical outcome measures at study visits 1, 3 (3 months) 4 at (6 months) and 5 (12 months will include: VAS (Visual analog Global pain (1-10), SF -36 ,WOMAC questionnaires (Western Ontario and McMaster University Arthritis Index pain Scale), measured distance on 6 minute walking distance test and synovial fluid depth measured by ultrasound. The Synovial fluid biomarker panel will include values of over 45 separate cytokines,.chemokines and proteins from subjects pre vs post Hymovis injections and compared to values in the peripheral blood obtained simultaneously. SF biomarker analysis will be performed on cryopreserved samples using fluorescence multiplex bead based assays (Luminex) or by ELISA. All values as well as clinical outcome parameters will be entered into the REDCap system for statistical analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with mild to moderate(on x rays) symptomatic knee osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate knee osteoarthritis on x ray\n* age 21-80\n\nExclusion Criteria\n\n* pregnant\n* BMI \\> 40\n* history of systemic immune disorders\n* knee arthroplasty with replacement\n* knee infection or surgery within 1 year\n* glucocorticoid injection within 3 months inability to ambulate for 6 minutes without walking assistive devices\n* unable to provide informed consent\n* patients with a clinical contra-indication for an arthrocentesis or adverse reaction to prior intra-articular lidocaine or HA injections.'}, 'identificationModule': {'nctId': 'NCT04093232', 'briefTitle': 'Synovial Fluid Biomarkers Pre and Post Hymovis Knee Injection', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Alterations in Knee Synovial Fluid Biomarkers and Volume Following Hymovis Injections Using a Pneumatic Assistive Compression Device and Ultrasound Guided Arthrocentesis: Correlation With Clinical Outcomes', 'orgStudyIdInfo': {'id': 'HS 3179'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hymovis', 'type': 'DRUG', 'description': 'All subjects will receive 2 ultrasound guided Hymovis injections and the goal of the study is to correlate responsiveness to subjects unique SF biomarker panel results before the first Hymovis injection and identify potential mechanism of action of those OA patients who receive the greatest benefit.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Gill, RN', 'role': 'CONTACT', 'email': 'Gillm@njhealth.org', 'phone': '303-398-1443'}, {'name': 'richard T Meehan, MD', 'role': 'CONTACT', 'email': 'meehanr@njhealth.org', 'phone': '303 398-1474'}], 'facility': 'national Jewish health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Mary Gill, MD', 'role': 'CONTACT', 'email': 'gillm@njHealth.org', 'phone': '303 398 1443'}, {'name': 'richard T Meehan, MD', 'role': 'CONTACT', 'email': 'meehanr@njHealth.org', 'phone': '303 398-1475'}], 'overallOfficials': [{'name': 'Richard T Meehan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nnational Jewish health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Only de-identified SF cryopreserved samples may be made available to potential collaborators in the future.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Jewish Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fidia Pharma USA Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Richard Meehan', 'investigatorAffiliation': 'National Jewish Health'}}}}