Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-02-25 @ 6:58 PM
Study NCT ID:
NCT02951403
Status:
UNKNOWN
Last Update Posted:
2019-09-17
First Post:
2016-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results of the Treatment of Patients With Elbow Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quick DASH score', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': 'VAS score', 'timeFrame': '24 Months'}, {'measure': 'Range of motion', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elbow arthroscopy', 'DASH', 'elbow locking', 'elbow osteoarthritis'], 'conditions': ['Elbow Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The study is a prospective case controlled clinical trial. The purpose of the study is to investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow when compared to conservative treatment.', 'detailedDescription': 'Patients will be recruited at departments of hand surgery and orthopedic surgery outpatient clinics. The control group will be patients to whom the conservative treatment continues. Patients who meet the inclusion criteria will be asked to participate and sign the informed consent. Therefore the investigators have two treatment groups: group 1 who receives an elbow joint debridement arthroscopically without physiotherapy and group 2 who receives only conservative treatment with physiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic post-traumatic or primary osteoarthritis - mechanical locking and/or decreased range of motion ( \\>30°)\n* Radiographic evidence of at least mild primary or post-traumatic osteoarthritis according to Broberg - Morrey classification symptoms lasting at least 6 months\n* Patients willingness to participate the study\n* All patients 18-80 ages\n\nExclusion Criteria:\n\n* Patients with previous severe soft tissue trauma at elbow region ( crush, burns etc - the elbow joint problems are not joint specific)\n* Patients with crystal arthropathy or inflammatory arthritis\n* Patient refuses to participate the study\n* Patients with dementia or are institutionalized\n* Patients with severe substance addiction\n* Patient does not understand written and spoken guidance'}, 'identificationModule': {'nctId': 'NCT02951403', 'briefTitle': 'Results of the Treatment of Patients With Elbow Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Results of the Treatment of Patients With Elbow Osteoarthritis', 'orgStudyIdInfo': {'id': 'R15117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Operative treatment', 'description': 'Patients to whom the elbow arthroscopy will be performed.', 'interventionNames': ['Procedure: Elbow arthroscopy']}, {'type': 'OTHER', 'label': 'Conservative treatment', 'description': 'Patients to whom special physiotherapy will be advised.', 'interventionNames': ['Other: Conservative treatment']}], 'interventions': [{'name': 'Elbow arthroscopy', 'type': 'PROCEDURE', 'description': 'Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.', 'armGroupLabels': ['Operative treatment']}, {'name': 'Conservative treatment', 'type': 'OTHER', 'description': 'Physiotherapy protocol is introduced to patients.', 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40620', 'city': 'Jyväskylä', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Toni Luokkala, MD', 'role': 'CONTACT', 'email': 'toni.luokkala@ksshp.fi', 'phone': '+35814 2691811'}], 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '33230', 'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Margit Karelson, MD', 'role': 'CONTACT', 'email': 'margit.karelson@gmail.com', 'phone': '+358 3 311 66071'}, {'name': 'Margit Karelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antti Launonen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janne Lehtinen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '33900', 'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Janne Lehtinen, MD, PhD', 'role': 'CONTACT', 'email': 'janne.lehtinen@tampere.fi', 'phone': '+358 3 565713'}], 'facility': 'Tampere University Hospital, Hatanpää', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Margit Karelson, MD', 'role': 'CONTACT', 'email': 'margit.karelson@pshp.fi', 'phone': '+358 3 311 66071'}, {'name': 'Antti Launonen, MD, PhD', 'role': 'CONTACT', 'email': 'antti.launonen@pshp.fi', 'phone': '+358 3 311 69595'}], 'overallOfficials': [{'name': 'Ville Mattila, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}, {'name': 'Margit Karelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hand surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Finland Hospital District', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}