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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Arizona

About this trial

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 criteria

Qualifiers

18-40 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,

Disqualifiers

< 18, >41 years of age,

prior bone patellar bone anterior cruciate ligament reconstruction,

non-compliance post-operatively,

nicotine dependence.

Trial design

Treatments tested in this trial

  • autologous bone grafts
  • Demineralized bone matrix (DBM)

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators