Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04953702
Status:
WITHDRAWN
Last Update Posted:
2024-09-26
First Post:
2021-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not a clinical trial/IRB Approval Lapsed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions', 'timeFrame': '12 months', 'description': 'The proportion of patients with subchondral insufficiency fractures and coexisting conditions (overall and per condition) as compared to those without coexisting conditions.\n\nCoexisting conditions are identified and defined through metabolic and musculoskeletal-related findings from available lab and radiological results in the patient medical record, such as those related to diabetes, obesity, osteoarthritis and other orthopedic related conditions and metabolic issues.'}], 'secondaryOutcomes': [{'measure': 'Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level)', 'timeFrame': '12 months', 'description': 'The proportions of patients with improvement in pain, worsening of pain, or no change in pain per prescribed treatment.\n\nChanges in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse).'}, {'measure': 'Correlation between activity level and treatment outcome (pain level)', 'timeFrame': '12 months', 'description': "The proportions of patients with improvement in pain, worsening of pain, or no change in pain based on activity level.\n\nChanges in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse).\n\nActivity level collected via interviews (exercise type/duration/frequency). Activity level categorized into none/mild/moderate/high exertion based on the following criteria:\n\n* MILD=pool, chair yoga, golf w/ cart\n* MODERATE=land-based exercise/standing/walking/cycling, golf w/out cart\n* HIGH=can't talk while exercising, running/cycling\\>10miles, jumping, boot camp"}, {'measure': 'Correlation between coexisting conditions and treatment outcome (pain level)', 'timeFrame': '12 months', 'description': 'The proportions of patients with improvement in pain, worsening of pain, or no change in pain based on presence or absence of coexisting conditions (overall, per condition).\n\nChanges in pain level identified by visual analog scale (VAS) and three-point scale (same/better/worse). The VAS includes subject identification of pain level from 0 (no pain) to 10 (worst pain). Change in pain level identified via VAS in evaluating numerical assessment provided by subjects over course of treatment (increase in rank = worsening; decrease in rank = improving; same rank = same). Change in pain level identified directly using the three point scale (same/better/worse).\n\nCoexisting conditions identified and defined through metabolic and MSK-related findings from available lab and radiological results in the medical record, such as those related to diabetes, obesity, osteoarthritis and other orthopedic related and metabolic issues.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Musculoskeletal diseases', 'Nutrition disorders', 'Pain'], 'conditions': ['Subchondral Insufficiency Fracture']}, 'descriptionModule': {'briefSummary': 'This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care and are not a member of a special population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.\n\nExclusion Criteria:\n\n* Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence will be excluded.\n\nThe following special populations will be excluded:\n\n* Adults unable to consent and/or unable to follow two-step commands\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners\n* Non-English-speaking patients'}, 'identificationModule': {'nctId': 'NCT04953702', 'briefTitle': 'Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Insufficiency Fractures of the Knee: Insufficient of Nutrients or Cartilage?', 'orgStudyIdInfo': {'id': 'H00023240'}}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Health', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Lauren Scarpetti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}