NCT06975306

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025May 2026

Study Start

First participant enrolled

February 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

April 21, 2025

Last Update Submit

May 14, 2025

Conditions

Bone Graft; ComplicationsACL Injuries

Outcome Measures

Primary Outcomes (5)

  • change in surgical time

    Duration of Procedure

  • Change in number of complications from the coring reamer intra-operatively

    Duration of Procedure

  • Change in number of complications associated with displacement of the bone graft

    1 year post procedure

  • Change in outcomes by immediately filling the patellar void following BTB graft harvest

    Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale

    1 year post procedure

  • Change in outcomes by immediately filling the patellar void following BTB graft harvest

    Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System

    1 year post procedure

Study Arms (2)

autologous bone graft

EXPERIMENTAL

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

Procedure: autologous bone grafts

Demineralized bone matrix (DBM) putty

EXPERIMENTAL

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.

Other: Demineralized bone matrix (DBM)

Interventions

autologous bone graftsPROCEDURE

group will be treated with autologous bone graft for BTB ACLR

autologous bone graft
Demineralized bone matrix (DBM)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.

Demineralized bone matrix (DBM) putty

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 may not qualify if:

  • \< 18, \>41 years of age,
  • prior bone patellar bone anterior cruciate ligament reconstruction,
  • non-compliance post-operatively,
  • nicotine dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Banner Health Center Plus - Arcadia

Phoenix, Arizona, 85008, United States

RECRUITING

Banner Sports Medicine Scottsdale

Scottsdale, Arizona, 85256, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 27357530BACKGROUND

  • 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.

    PMID: 31496049BACKGROUND

  • 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.

    PMID: 35936861BACKGROUND

  • 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.

    PMID: 11476385BACKGROUND

  • 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

    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

    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.

    PMID: 30987906BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Grafton demineralized bone matrix gel

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Anup Shah, MD

    College of Medicine - Phoenix

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marleny Munoz

CONTACT

602-793-9582marlenymunoz@arizona.edu

Phoenix Biomedical Campus Regulatory Team

CONTACT

mlburchfi@arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Program Director, Orthopaedic Sports Medicine

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 16, 2025

Study Start

February 11, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)