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

Not Applicable

Completed

• Conditions: ACL
• Interventions: Device: DBM; Device: Calcium phosphate cement; Other: Autologous bone graft

• Registration Number: NCT04533880
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study Start: 2020-08-31
• Study First Posted: 2020-09-01
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Status Verified: 2024-07
• Results First Submitted: 2024-07-19
• Results First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Bone + DBM	DBM	Autologous bone plus demineralized bone matrix
Autologous Bone + DBM	Autologous bone graft	Autologous bone plus demineralized bone matrix
Control	Autologous bone graft	The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous Bone + Calcium Phosphate Cement	Calcium phosphate cement	Autologous bone plus calcium phosphate cement
Autologous Bone + Calcium Phosphate Cement	Autologous bone graft	Autologous bone plus calcium phosphate cement

Primary Outcome Measures

Name	Time	Method
Score on Kujala Anterior Knee Pain Scale (AKPS)	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.
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey	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.
Change in VAS Score for Anterior Knee Pain	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.

Trial Locations

Locations (1)

NYU Langone Orthopedic Hospital; 🇺🇸 New York, New York, United States