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

NYU Langone Health150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

ACL

Interventions

DBMDEVICE

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

Calcium phosphate cementDEVICE

Quickset, Arthrex, Naples, FL

Autologous bone graftOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Orthopedic Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey

The KOOS survery comprises 42 questions; questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), quality of life (4 questions). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain / higher difficulty in function.

Time frame: Month 12 Post-Op

Score on Kujala Anterior Knee Pain Scale (AKPS)

The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain.

Time frame: Month 12 Post-Op

Change in VAS Score for Anterior Knee Pain

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score range is 0-100; the higher the score, the worse the pain.

Time frame: Baseline, Month 12 Post-Op

Data from ClinicalTrials.gov

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