The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction

NCT ID: NCT04533880

Last Updated: 2024-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2023-07-07

Brief Summary

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One of the common complaints after ACLR with BPTB autograft anterior knee pain. It is thought that this may be due to harvesting the patellar tendon for graft use. Specifically, this may be due to the bone defect that is left after graft harvesting. There is currently no consensus on a gold standard for treating the bone defect with surgeons using multiple commercially available bone void fillers as well as autologous bone graft in standard practice.

The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee pain following ACL reconstruction BPTB autograft.

Detailed Description

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Conditions

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ACL

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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Control

The control group will receive autologous bone obtained from the BTBPB graft harvest

Group Type PLACEBO_COMPARATOR

Autologous bone graft

Intervention Type OTHER

Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Autologous Bone + DBM

Autologous bone plus demineralized bone matrix

Group Type ACTIVE_COMPARATOR

DBM

Intervention Type DEVICE

Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)

Autologous bone graft

Intervention Type OTHER

Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Autologous Bone + Calcium Phosphate Cement

Autologous bone plus calcium phosphate cement

Group Type ACTIVE_COMPARATOR

Calcium phosphate cement

Intervention Type DEVICE

Quickset, Arthrex, Naples, FL

Autologous bone graft

Intervention Type OTHER

Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Interventions

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DBM

Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)

Intervention Type DEVICE

Calcium phosphate cement

Quickset, Arthrex, Naples, FL

Intervention Type DEVICE

Autologous bone graft

Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing ACLR with BPTB autograft
* Skeletally mature (as defined by closed growth plates on plain radiograph)
* At least 18 years of age
* Willing and able to provide consent

Exclusion Criteria

* knee with intact ACL
* skeletally immature (as defined by open physis on plain radiograph)
* pregnant
* less than 18 years of age
* previous ACL repair or reconstruction
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Strauss, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Orthopedic Hospital

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-00081

Identifier Type: -

Identifier Source: org_study_id

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