Clinical trial NCT06975306: Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
Official title: Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Graft; Complications
ACL Injuries
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: change in surgical time
timeFrame: Duration of Procedure
measure: Change in number of complications from the coring reamer intra-operatively
timeFrame: Duration of Procedure
measure: Change in number of complications associated with displacement of the bone graft
timeFrame: 1 year post procedure
measure: Change in outcomes by immediately filling the patellar void following BTB graft harvest
timeFrame: 1 year post procedure
measure: Change in outcomes by immediately filling the patellar void following BTB graft harvest
timeFrame: 1 year post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Banner Health Center Plus - Arcadia
state: Arizona
city: Scottsdale
country: United States
facility: Banner Sports Medicine Scottsdale
state: Arizona
Study officials:
affiliation: College of Medicine - Phoenix
name: Anup Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007/s00264-016-3246-8. Epub 2016 Jun 29.
citation: Zhang H, Yang L, Yang XG, Wang F, Feng JT, Hua KC, Li Q, Hu YC. Demineralized Bone Matrix Carriers and their Clinical Applications: An Overview. Orthop Surg. 2019 Oct;11(5):725-737. doi: 10.1111/os.12509. Epub 2019 Sep 8.
citation: Leafblad ND, Maak TG. Bone Grafting Technique in Revision ACL Reconstruction: Coring Reamer and Dowel Trick. Arthrosc Tech. 2022 Jun 21;11(7):e1367-e1372. doi: 10.1016/j.eats.2022.03.024. eCollection 2022 Jul.
citation: Tsuda E, Okamura Y, Ishibashi Y, Otsuka H, Toh S. Techniques for reducing anterior knee symptoms after anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft. Am J Sports Med. 2001 Jul-Aug;29(4):450-6. doi: 10.1177/03635465010290041201.
citation: Radiological Society of North America (RSNA) and American College of Radiology (ACR). (2022, November 1). Radiation Dose. Radiologyinfo.org. https://www.radiologyinfo.org/en/info/safety-xrayMedical research
citation: J. M. Erdal, I. Vik, a. P. Parkar; Bergen/NO & European Society of Radiology. (n.d.). Assessment of effective dose in a series of CT of the knees, time to revise the guidelines? In EPOS. ECR 2016. https://dx.doi.org/10.1594/ecr2016/C-0205
citation: Su AW, Hillen TJ, Eutsler EP, Bedi A, Ross JR, Larson CM, Clohisy JC, Nepple JJ. Low-Dose Computed Tomography Reduces Radiation Exposure by 90% Compared With Traditional Computed Tomography Among Patients Undergoing Hip-Preservation Surgery. Arthroscopy. 2019 May;35(5):1385-1392. doi: 10.1016/j.arthro.2018.11.013. Epub 2019 Apr 12.