Recruiting

Bone Grafting

Sponsor:

University of Arizona

Code:

NCT06975306

Conditions

Bone Graft; Complications

ACL Injuries

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

autologous bone grafts

Demineralized bone matrix (DBM)

Study Details

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.

Conditions

Bone Graft; Complications

ACL Injuries

Study ID

NCT06975306

Start date

Feb 11, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

autologous bone grafts

group will be treated with autologous bone graft for BTB ACLR

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.

Primary outcome measure

  • change in surgical time [ Time Frame: Duration of Procedure ]
  • Change in number of complications from the coring reamer intra-operatively [ Time Frame: Duration of Procedure ]
  • Change in number of complications associated with displacement of the bone graft [ Time Frame: 1 year post procedure ]
  • 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 [ Time Frame: 1 year post procedure ]

Central Contacts and Locations

Central contacts

Marleny Munoz

602-793-9582marlenymunoz@arizona.edu

Phoenix Biomedical Campus Regulatory Team

mlburchfi@arizona.edu

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Marleny Munoz

602-793-9582marlenymunoz@arizona.edu

Banner Health Center Plus - Arcadia

Recruiting

Phoenix, Arizona, United States, 85008

Contacts

Marleny Munoz

602-793-9582marlenymunoz@arizona.edu

Banner Sports Medicine Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85256

Contacts

Marleny Munoz

602-793-9582marlenymunoz@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-08-14.