ACL Injuries, Bone Graft; Complications
Conditions
Brief 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.
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.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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, * compliant post operative course.
Exclusion criteria
* \< 18, \>41 years of age, * prior bone patellar bone anterior cruciate ligament reconstruction, * non-compliance post-operatively, * nicotine dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in surgical time | Duration of Procedure | — |
| Change in number of complications from the coring reamer intra-operatively | Duration of Procedure | — |
| Change in number of complications associated with displacement of the bone graft | 1 year post procedure | — |
| Change in outcomes by immediately filling the patellar void following BTB graft harvest | 1 year post procedure | Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale |
Countries
United States
Contacts
CONTACTMarleny Munoz
CONTACTPhoenix Biomedical Campus Regulatory Team
PRINCIPAL_INVESTIGATORAnup Shah, MD
College of Medicine - Phoenix
Outcome results
None listed