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

Purpose

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.

Conditions

  • Bone Graft; Complications
  • ACL Injuries

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
autologous bone graft 		One group will be treated with autologous bone graft for BTB ACLR
  • Procedure: autologous bone grafts
    group will be treated with autologous bone graft for BTB ACLR
Experimental
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.
  • Other: 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.

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Marleny Munoz
602-793-9582
marlenymunoz@arizona.edu

Banner Health Center Plus - Arcadia
Phoenix, Arizona 85008
Contact:
Marleny Munoz
602-793-9582
marlenymunoz@arizona.edu

Banner Sports Medicine Scottsdale
Scottsdale, Arizona 85256
Contact:
Marleny Munoz
602-793-9582
marlenymunoz@arizona.edu

More Details

NCT ID
NCT06975306
Status
Recruiting
Sponsor
University of Arizona

Study Contact

Marleny Munoz
602-793-9582
marlenymunoz@arizona.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center