Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction (BTB BackFill)

University of Arizona

Status: Enrolling

Conditions: ACL Injuries; Bone Graft; Complications

Treatments: Procedure: autologous bone grafts; Other: Demineralized bone matrix (DBM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06975306

STUDY00005122

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

autologous bone graft

Experimental group

Description:

One group will be treated with autologous bone graft for BTB ACLR

Treatment:

Procedure: autologous bone grafts

Demineralized bone matrix (DBM) putty

Experimental group

Description:

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.

Treatment:

Other: Demineralized bone matrix (DBM)