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NCT Number: NCT06975306

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

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.

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Key information

Conditions

Bone Graft; Complications ACL Injuries Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banner Health Center Plus - Arcadia, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. change in surgical time

    Time frame: Duration of Procedure

  2. Change in number of complications from the coring reamer intra-operatively

    Time frame: Duration of Procedure

  3. Change in number of complications associated with displacement of the bone graft

    Time frame: 1 year post procedure

  4. Change in outcomes by immediately filling the patellar void following BTB graft harvest

    Time frame: 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

  5. Change in outcomes by immediately filling the patellar void following BTB graft harvest

    Time frame: 1 year post procedure

    Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System

Study contacts

Contact information is provided by the study sponsor or research team.

Marleny Munoz

CONTACT

[email protected]

602-793-9582

Phoenix Biomedical Campus Regulatory Team

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Acronym: BTB BackFill

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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