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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
group will be treated with autologous bone graft for BTB ACLR
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.
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
RECRUITINGBanner Health Center Plus - Arcadia
Phoenix, Arizona, United States
RECRUITINGBanner Sports Medicine Scottsdale
Scottsdale, Arizona, United States
RECRUITINGchange in surgical time
Time frame: Duration of Procedure
Change in number of complications from the coring reamer intra-operatively
Time frame: Duration of Procedure
Change in number of complications associated with displacement of the bone graft
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System
Time frame: 1 year post procedure
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