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

The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft

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 Overview

• Status: Completed
• Conditions: ACL
• Intervention / Treatment: Other: Autologous bone graft; Device: DBM; Device: Calcium phosphate cement

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Langone Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; The control group will receive autologous bone obtained from the BTBPB graft harvest	Other: Autologous bone graft; Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Active Comparator: Autologous Bone + DBM; Autologous bone plus demineralized bone matrix	Other: Autologous bone graft; Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft; Device: DBM; Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Active Comparator: Autologous Bone + Calcium Phosphate Cement; Autologous bone plus calcium phosphate cement	Other: Autologous bone graft; Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft; Device: Calcium phosphate cement; Quickset, Arthrex, Naples, FL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 12 Post-Op
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.	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.	Baseline, Month 12 Post-Op

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eric Strauss, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 20-00081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to eric.strauss@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes