What this study is
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.
What's being tested
- autologous bone grafts
Intervention · PROCEDURE
group will be treated with autologous bone graft for BTB ACLR
- Demineralized bone matrix (DBM)
Intervention · 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
- Sponsor
- University of Arizona
- Conditions
- Bone Graft; Complications · ACL Injuries
- Enrolling
- 75 people
- Starts
- 2025-02-11
- Est. completion
- 2027-04-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 40 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- < 18, >41 years of age,
- Prior bone patellar bone anterior cruciate ligament reconstruction,
- Non-compliance post-operatively,
- Nicotine dependence.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Marleny Munoz · Contact602-793-9582marlenymunoz@arizona.edu
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
RecruitingBanner Health Center Plus - Arcadia
Phoenix, Arizona, United States
RecruitingBanner Sports Medicine Scottsdale
Scottsdale, Arizona, United States
Recruiting
Study team
Sponsor
University of Arizona
Study ID STUDY00005122
Principal investigator
Anup Shah, MD
College of Medicine - Phoenix
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.