Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-30 @ 1:47 PM
Study NCT ID:
NCT06975306
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C497176', 'term': 'Grafton demineralized bone matrix gel'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in surgical time', 'timeFrame': 'Duration of Procedure'}, {'measure': 'Change in number of complications from the coring reamer intra-operatively', 'timeFrame': 'Duration of Procedure'}, {'measure': 'Change in number of complications associated with displacement of the bone graft', 'timeFrame': '1 year post procedure'}, {'measure': 'Change in outcomes by immediately filling the patellar void following BTB graft harvest', 'timeFrame': '1 year post procedure', 'description': 'Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale'}, {'measure': 'Change in outcomes by immediately filling the patellar void following BTB graft harvest', 'timeFrame': '1 year post procedure', 'description': 'Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Graft; Complications', 'ACL Injuries']}, 'referencesModule': {'references': [{'pmid': '27357530', 'type': 'BACKGROUND', 'citation': 'Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007/s00264-016-3246-8. Epub 2016 Jun 29.'}, {'pmid': '31496049', 'type': 'BACKGROUND', 'citation': 'Zhang H, Yang L, Yang XG, Wang F, Feng JT, Hua KC, Li Q, Hu YC. Demineralized Bone Matrix Carriers and their Clinical Applications: An Overview. Orthop Surg. 2019 Oct;11(5):725-737. doi: 10.1111/os.12509. Epub 2019 Sep 8.'}, {'pmid': '35936861', 'type': 'BACKGROUND', 'citation': 'Leafblad ND, Maak TG. Bone Grafting Technique in Revision ACL Reconstruction: Coring Reamer and Dowel Trick. Arthrosc Tech. 2022 Jun 21;11(7):e1367-e1372. doi: 10.1016/j.eats.2022.03.024. eCollection 2022 Jul.'}, {'pmid': '11476385', 'type': 'BACKGROUND', 'citation': 'Tsuda E, Okamura Y, Ishibashi Y, Otsuka H, Toh S. Techniques for reducing anterior knee symptoms after anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft. Am J Sports Med. 2001 Jul-Aug;29(4):450-6. doi: 10.1177/03635465010290041201.'}, {'type': 'BACKGROUND', 'citation': 'Radiological Society of North America (RSNA) and American College of Radiology (ACR). (2022, November 1). Radiation Dose. Radiologyinfo.org. https://www.radiologyinfo.org/en/info/safety-xrayMedical research'}, {'type': 'BACKGROUND', 'citation': 'J. M. Erdal, I. Vik, a. P. Parkar; Bergen/NO & European Society of Radiology. (n.d.). Assessment of effective dose in a series of CT of the knees, time to revise the guidelines? In EPOS. ECR 2016. https://dx.doi.org/10.1594/ecr2016/C-0205'}, {'pmid': '30987906', 'type': 'BACKGROUND', 'citation': 'Su AW, Hillen TJ, Eutsler EP, Bedi A, Ross JR, Larson CM, Clohisy JC, Nepple JJ. Low-Dose Computed Tomography Reduces Radiation Exposure by 90% Compared With Traditional Computed Tomography Among Patients Undergoing Hip-Preservation Surgery. Arthroscopy. 2019 May;35(5):1385-1392. doi: 10.1016/j.arthro.2018.11.013. Epub 2019 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old,\n* male/female/gender neutral,\n* all races not including vulnerable/special consideration populations,\n* candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,\n* compliant post operative course.\n\nExclusion Criteria:\n\n* \\< 18, \\>41 years of age,\n* prior bone patellar bone anterior cruciate ligament reconstruction,\n* non-compliance post-operatively,\n* nicotine dependence.'}, 'identificationModule': {'nctId': 'NCT06975306', 'acronym': 'BTB BackFill', 'briefTitle': 'Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction', 'orgStudyIdInfo': {'id': 'STUDY00005122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous bone graft', 'description': 'One group will be treated with autologous bone graft for BTB ACLR', 'interventionNames': ['Procedure: autologous bone grafts']}, {'type': 'EXPERIMENTAL', 'label': 'Demineralized bone matrix (DBM) putty', 'description': 'Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.', 'interventionNames': ['Other: Demineralized bone matrix (DBM)']}], 'interventions': [{'name': 'autologous bone grafts', 'type': 'PROCEDURE', 'description': 'group will be treated with autologous bone graft for BTB ACLR', 'armGroupLabels': ['autologous bone graft']}, {'name': 'Demineralized bone matrix (DBM)', 'type': 'OTHER', 'description': 'Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.', 'armGroupLabels': ['Demineralized bone matrix (DBM) putty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marleny Munoz', 'role': 'CONTACT', 'email': 'marlenymunoz@arizona.edu', 'phone': '602-793-9582'}], 'facility': 'Banner University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marleny Munoz', 'role': 'CONTACT', 'email': 'marlenymunoz@arizona.edu', 'phone': '602-793-9582'}], 'facility': 'Banner Health Center Plus - Arcadia', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85256', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marleny Munoz', 'role': 'CONTACT', 'email': 'marlenymunoz@arizona.edu', 'phone': '602-793-9582'}], 'facility': 'Banner Sports Medicine Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Marleny Munoz', 'role': 'CONTACT', 'email': 'marlenymunoz@arizona.edu', 'phone': '602-793-9582'}, {'name': 'Phoenix Biomedical Campus Regulatory Team', 'role': 'CONTACT', 'email': 'mlburchfi@arizona.edu'}], 'overallOfficials': [{'name': 'Anup Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Medicine - Phoenix'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Program Director, Orthopaedic Sports Medicine', 'investigatorFullName': 'Anup Shah', 'investigatorAffiliation': 'University of Arizona'}}}}