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

NCT ID: NCT06975306

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Graft; Complications ACL Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous bone graft

One group will be treated with autologous bone graft for BTB ACLR

Group Type EXPERIMENTAL

autologous bone grafts

Intervention Type PROCEDURE

group will be treated with autologous bone graft for BTB ACLR

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.

Group Type EXPERIMENTAL

Demineralized bone matrix (DBM)

Intervention Type 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.

Interventions

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autologous bone grafts

group will be treated with autologous bone graft for BTB ACLR

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Anup Shah

Associate Program Director, Orthopaedic Sports Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anup Shah, MD

Role: PRINCIPAL_INVESTIGATOR

College of Medicine - Phoenix

Locations

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Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

Banner Health Center Plus - Arcadia

Phoenix, Arizona, United States

Site Status RECRUITING

Banner Sports Medicine Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marleny Munoz

Role: CONTACT

602-793-9582

Phoenix Biomedical Campus Regulatory Team

Role: CONTACT

Facility Contacts

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Marleny Munoz

Role: primary

602-793-9582

Marleny Munoz

Role: primary

602-793-9582

Marleny Munoz

Role: primary

602-793-9582

References

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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.

Reference Type BACKGROUND
PMID: 27357530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31496049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35936861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11476385 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30987906 (View on PubMed)

Other Identifiers

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STUDY00005122

Identifier Type: -

Identifier Source: org_study_id

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