Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-03-12 @ 7:27 PM
Study NCT ID:
NCT04973995
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Optimization of Rotator Cuff Injury Diagnosis Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Accuracy of different physical examinations', 'timeFrame': '1week', 'description': 'After apply these physical examinations, by using Arthroscopic examination find the accuracy of these physical examinations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical examination', 'Rotator cuff', 'LHBT'], 'conditions': ['Rotator Cuff Injury']}, 'descriptionModule': {'briefSummary': 'Rotator cuff injury is a common cause of shoulder pain and dysfunction. Finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.\n\nHow to apply multiple physical examination programs to make judgments sensitively, efficiently and accurately is a clinical problem that needs to be solved urgently.', 'detailedDescription': 'Rotator cuff injury is a common cause of shoulder pain and dysfunction. The common symptoms of rotator cuff injury include shoulder pain, weakness, and limited mobility. Arthroscopic exploration is the gold standard for the diagnosis of rotator cuff injury, but it is an invasive examination that is difficult to carry out routinely; MRI is sensitive in diagnosing rotator cuff tears Both sex and specificity are high, but due to the popularity, cost and waiting time, it is difficult to be used as a routine screening method.\n\nTherefore, finding patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assisting in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.\n\nHowever, although there are many physical examination methods for the shoulder joint, the accuracy of each method is different, and each has its own sensitivity and specificity. How to apply multiple examination programs in combination to make it sensitive, efficient and accurate Judgment is a problem that needs to be solved clinically.\n\nThis study is expected to adopt prospective research methods to collect and collect patient medical records, preoperative physical examination results, imaging data, and findings during intraoperative exploration, to understand the impact of various shoulder joint physical examination methods and imaging data on rotator cuff injuries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with shoulder pain who were treated at peking university's Third Hospital outpatient clinic for a continuous period of time", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are prepared to undergo arthroscopic surgery for shoulder injuries\n\nExclusion Criteria:\n\n* Shoulder stiffness, shoulder instability, calcified tendinitis, past surgery, side-to-shoulder disease, hamada osteoarthritis, frozen shoulder, acute joint injury, rheumatoid arthritis, hyperuricemia'}, 'identificationModule': {'nctId': 'NCT04973995', 'briefTitle': 'Research on Optimization of Rotator Cuff Injury Diagnosis Plan', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Research on Optimization of Rotator Cuff Injury Diagnosis Plan', 'orgStudyIdInfo': {'id': 'M2021099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with shoulder pain who received ER lag sign', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': 'Patients with shoulder pain who received External rotation resistence strength test', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': "Patients with shoulder pain who received Patte's test", 'interventionNames': ['Behavioral: several physical examinations']}, {'label': 'Patients with shoulder pain who received Errsair test', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': 'Patients with shoulder pain who received speed test', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': 'Patients with shoulder pain who received Yergason test', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': 'Patients with shoulder pain who received backward traction test', 'interventionNames': ['Behavioral: several physical examinations']}, {'label': "Patients with shoulder pain who received Cui's test", 'interventionNames': ['Behavioral: several physical examinations']}], 'interventions': [{'name': 'several physical examinations', 'type': 'BEHAVIORAL', 'description': 'By using physical examinations, the incidence of these physical examinations corresponding to shoulder muscls injury', 'armGroupLabels': ["Patients with shoulder pain who received Cui's test", 'Patients with shoulder pain who received ER lag sign', 'Patients with shoulder pain who received Errsair test', 'Patients with shoulder pain who received External rotation resistence strength test', "Patients with shoulder pain who received Patte's test", 'Patients with shoulder pain who received Yergason test', 'Patients with shoulder pain who received backward traction test', 'Patients with shoulder pain who received speed test']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guoqing Cui, MD', 'role': 'CONTACT', 'email': 'cgq3019@vip.163.com', 'phone': '15611908685'}], 'overallOfficials': [{'name': 'Guoqing Cui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}