Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
NCT ID: NCT06975306
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-02-11
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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autologous bone graft
One group will be treated with autologous bone graft for BTB ACLR
autologous bone grafts
group will be treated with autologous bone graft for BTB ACLR
Demineralized bone matrix (DBM) putty
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.
Demineralized bone matrix (DBM)
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.
Interventions
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autologous bone grafts
group will be treated with autologous bone graft for BTB ACLR
Demineralized bone matrix (DBM)
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.
Eligibility Criteria
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Inclusion Criteria
* male/female/gender neutral,
* all races not including vulnerable/special consideration populations,
* candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,
* compliant post operative course.
Exclusion Criteria
* prior bone patellar bone anterior cruciate ligament reconstruction,
* non-compliance post-operatively,
* nicotine dependence.
18 Years
40 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Anup Shah
Associate Program Director, Orthopaedic Sports Medicine
Principal Investigators
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Anup Shah, MD
Role: PRINCIPAL_INVESTIGATOR
College of Medicine - Phoenix
Locations
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Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Banner Health Center Plus - Arcadia
Phoenix, Arizona, United States
Banner Sports Medicine Scottsdale
Scottsdale, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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
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
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.
Other Identifiers
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STUDY00005122
Identifier Type: -
Identifier Source: org_study_id
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