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NCT Number: NCT04533880

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

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.

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Key information

Conditions

ACL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Orthopedic Hospital

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBM

Device

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

Calcium phosphate cement

Device

Quickset, Arthrex, Naples, FL

Autologous bone graft

Other

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

Primary outcomes

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

    Time frame: Month 12 Post-Op

    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.

  2. Score on Kujala Anterior Knee Pain Scale (AKPS)

    Time frame: Month 12 Post-Op

    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.

  3. Change in VAS Score for Anterior Knee Pain

    Time frame: Baseline, Month 12 Post-Op

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2020
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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