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

Conditions

• ACL Injuries
• Bone Graft; Complications

Eligibility Criteria

Sex

ALL

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• autologous bone grafts — PROCEDURE
  group will be treated with autologous bone graft for BTB ACLR
• Demineralized bone matrix (DBM) — OTHER
  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.

Study Details

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.

Key Dates

Start date

Feb 11, 2025

Status verified

May 2025

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: autologous bone graft
  One 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.

Primary Outcome Measure

change in surgical time [ Time Frame: Duration of Procedure ]

Central Contacts

• Marleny Munoz
  602-793-9582
  [email protected]
• Phoenix Biomedical Campus Regulatory Team
  [email protected]

Locations (3)

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