Comparing bone graft options for ACL reconstruction
Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
This study tests which type of bone graft, either a patient's own bone or a special putty, works better for people getting surgery to fix a torn ACL.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT06975306 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of two different bone grafting techniques used during anterior cruciate ligament reconstruction (ACLR). Patients will be randomly assigned to receive either an autologous bone graft or a commercially available demineralized bone matrix putty. The study will assess patient-reported outcomes and clinical evaluations, including pain levels, range of motion, and radiographic changes. Participants will be monitored before and after surgery to determine the effectiveness of each graft type.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 who are scheduled for ACL reconstruction using a bone patellar tendon bone autograft.
Not a fit: Patients outside the age range of 18-41, those with prior ACL reconstruction, or individuals who are non-compliant post-operatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing ACL reconstruction.
How similar studies have performed: Previous studies have explored various grafting techniques in ACL reconstruction, indicating potential for success, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 2 other locations
- Banner University Medical Center Phoenix — Phoenix, Arizona, United States (Recruiting)
- Banner Health Center Plus - Arcadia — Phoenix, Arizona, United States (Recruiting)
- Banner Sports Medicine Scottsdale — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Anup Shah, MD — College of Medicine - Phoenix
- Study coordinator: Marleny Munoz
- Email: marlenymunoz@arizona.edu
- Phone: 602-793-9582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.