Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-06 @ 3:41 PM
Study NCT ID:
NCT04471259
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2020-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013223', 'term': 'Statistics as Topic'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodex results on both sides before surgery', 'timeFrame': 'pre-surgery', 'description': "Biodex isokinetic muscle testing system was applied in this research. Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before. The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties. Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery."}, {'measure': 'Biodex results on both sides at 3 months', 'timeFrame': '3 months after surgery', 'description': 'Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.'}, {'measure': 'Biodex results on both sides at 6 months', 'timeFrame': '6 months after surgery', 'description': 'Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Haglund's Deformity", 'Biodex System', 'Isokinetic muscle testing', 'Endoscopy'], 'conditions': ["Haglund's Deformity"]}, 'descriptionModule': {'briefSummary': "Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Therefore, the present study is designed to examine the effectiveness of the muscle strength test using the Biodex system in evaluating the recovery of athletic capacity in patients with Haglund's deformity following endoscopic surgery.", 'detailedDescription': "Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The present study was approved by the Peking University Third Hospital's ethics committee. Written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. The rights of the patients were protected.\n\nDiagnosis. Patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. Radiological measurements for this disease include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet angle and the X/Y ratio."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of whom are professional athletes.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent endoscopic surgery for Haglund's deformity\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04471259', 'briefTitle': "Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity", 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': "Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity", 'orgStudyIdInfo': {'id': 'M2018151'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients' injured side", 'description': "The Biodex, AOFAS, VAS were tested on the patients' injured side", 'interventionNames': ['Other: Classification statistics']}, {'label': "Patients' uninjured side", 'description': "The Biodex, AOFAS, VAS were tested on the patients' uninjured side", 'interventionNames': ['Other: Classification statistics']}], 'interventions': [{'name': 'Classification statistics', 'type': 'OTHER', 'description': 'We classified patients by gender, age, recovery time,etc', 'armGroupLabels': ["Patients' injured side", "Patients' uninjured side"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}