RecruitingNot ApplicableNCT06975306

Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction


Sponsor

University of Arizona

Enrollment

75 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

  • years old,
  • 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 Criteria4

  • \< 18, \>41 years of age,
  • prior bone patellar bone anterior cruciate ligament reconstruction,
  • non-compliance post-operatively,
  • nicotine dependence.

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Interventions

PROCEDUREautologous bone grafts

group will be treated with autologous bone graft for BTB ACLR

OTHERDemineralized 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.


Locations(3)

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

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NCT06975306


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