Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT03792594
Status:
UNKNOWN
Last Update Posted:
2020-04-14
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Concentration for Rotator Cuff Tear
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-11', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-month postoperative shoulder function evaluated by Constant Shoulder Score', 'timeFrame': '3-month postoperative', 'description': 'Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.'}], 'secondaryOutcomes': [{'measure': '6-month postoperative shoulder function evaluated by Constant Shoulder Score', 'timeFrame': '6-month postoperative', 'description': 'Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.'}, {'measure': '12-month postoperative shoulder function evaluated by Constant Shoulder Score', 'timeFrame': '12-month postoperative', 'description': 'Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.'}, {'measure': '3-month postoperative degree of healing evaluated by plain radiograph', 'timeFrame': '3-month postoperative', 'description': 'Degree of healing evaluated by plain radiograph'}, {'measure': '6-month postoperative degree of healing evaluated by plain radiograph', 'timeFrame': '6-month postoperative', 'description': 'Degree of healing evaluated by plain radiograph'}, {'measure': '12-month postoperative degree of healing evaluated by plain radiograph', 'timeFrame': '12-month postoperative', 'description': 'Degree of healing evaluated by plain radiograph'}, {'measure': '6-month postoperative degree of healing evaluated by MRI', 'timeFrame': '6-month postoperative', 'description': 'Degree of healing evaluated by MRI'}, {'measure': '12-month postoperative degree of healing evaluated by MRI', 'timeFrame': '12-month postoperative', 'description': 'Degree of healing evaluated by MRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Marrow', 'Mesenchymal Stromal Cells', 'Rotator Cuff Tear'], 'conditions': ['Rotator Cuff Tear', 'Bone Marrow']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of bone marrow concentration on healing of rotator cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic repair with intraoperative bone marrow concentration and those receiving arthroscopic repair only.', 'detailedDescription': 'Rotator cuff tear is a common cause of pain and disability among adults. Most tears are largely caused by the normal wear and tear that goes along with aging. Although nonsurgical treatment relieves pain and improves function in the shoulder, surgical repair for a torn rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for rotator cuff tear. However, the healing of a repaired tendon is not always predictable. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve the healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on healing of rotator cuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With diagnosis of rotator cuff tear\n* Age between 40 and 70 years\n\nExclusion Criteria:\n\n* With prior history of shoulder surgery\n* With current or prior history of trauma or infection at shoulder\n* With current diagnosis of coagulopathy\n* With current or prior history of cancer\n* With current or prior history of hematological disease\n* Pregnancy\n* Patients who will not cooperate with one-year followup'}, 'identificationModule': {'nctId': 'NCT03792594', 'briefTitle': 'Autologous Bone Marrow Concentration for Rotator Cuff Tear', 'organization': {'class': 'OTHER', 'fullName': 'Show Chwan Memorial Hospital'}, 'officialTitle': 'The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear', 'orgStudyIdInfo': {'id': 'RD106055'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bone marrow concentration group', 'description': 'The patients receive arthroscopic repair with bone marrow concentration.', 'interventionNames': ['Other: arthroscopic repair with bone marrow concentration']}, {'label': 'Historical control group', 'description': 'The patients receive arthroscopic repair only', 'interventionNames': ['Other: arthroscopic repair']}], 'interventions': [{'name': 'arthroscopic repair with bone marrow concentration', 'type': 'OTHER', 'description': 'arthroscopic repair with bone marrow concentration', 'armGroupLabels': ['Bone marrow concentration group']}, {'name': 'arthroscopic repair', 'type': 'OTHER', 'description': 'arthroscopic repair only', 'armGroupLabels': ['Historical control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500', 'city': 'Changhua', 'state': 'Changhua', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Sheng Lo, MD', 'role': 'CONTACT', 'email': 'johnlcs@gmail.com', 'phone': '+886-975611289'}], 'facility': 'Show Chwan Memorial Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'centralContacts': [{'name': 'Chien-Sheng Lo, MD', 'role': 'CONTACT', 'email': 'johnlcs@gmail.com', 'phone': '+886-975611289'}, {'name': 'Pei-Yuan Lee, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Pei-Yuan Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Show Chwan Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pei-Yuan Lee, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aeon Biotechnology Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Superintendent', 'investigatorFullName': 'Pei-Yuan Lee, MD', 'investigatorAffiliation': 'Show Chwan Memorial Hospital'}}}}